Alternatives for Reducing Chorea in Huntington Disease
NCT01897896, Phase 3, Completed, Auspex Pharmaceuticals, Inc.; results first posted 2019-04-16
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Alternatives for Reducing Chorea in Huntington Disease | ClinicalTrials.gov |
| NCT number | NCT01897896 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 119 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Auspex Pharmaceuticals, Inc. | ClinicalTrials.gov |
| Conditions | Chorea Associated With Huntington Disease | ClinicalTrials.gov |
| Interventions | SD-809 | ClinicalTrials.gov |
| First posted | 2013-07-12 | ClinicalTrials.gov |
| Last updated | 2021-11-09 | ClinicalTrials.gov |
| Results first posted | 2019-04-16 | ClinicalTrials.gov |
Registered outcomes 40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Baseline to follow-up visit (up to approximately 3 years 9 months) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=inability to carry out usual activities. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | ClinicalTrials.gov |
| Primary | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Day 1 to end of Week 8 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | ClinicalTrials.gov |
| Primary | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Day 1 to end of Week 4 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | ClinicalTrials.gov |
| Primary | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Week 8 to follow-up visit (up to approximately 3 years 9 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets cells at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed values at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes mean corpuscular volume at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Hematocrit levels were calculated as the ratio of the volume of red cells to the volume of whole blood. Change from baseline in hematocrit at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Baseline, Week 158 | Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in hemoglobin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in alanine aminotransferase and alkaline phosphatase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in aspartate aminotransferase and lactate dehydrogenase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium and triglycerides at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in protein and albumin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Baseline, Week 106 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in creatinine clearance at baseline and Week 106 is reported in this outcome measure. Observed value at baseline and observed value at Week 106 were used to calculate the change from baseline value at Week 106. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Baseline, Week 158 | Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bilirubin, creatinine, direct bilirubin, and urate at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Blood Pressure at Week 171 | Baseline, Week 171 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Heart Rate at Week 171 | Baseline, Week 171 | Heart rate was assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Respiration Rate at Week 171 | Baseline, Week 171 | Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Body Temperature at Week 171 | Baseline, Week 171 | Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171. | ClinicalTrials.gov |
| Secondary | Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Baseline, Week 8 | ECG parameters included heart rate, PR interval, QRS duration, QT interval and Fridericia's corrected QT interval (QTcF). Heart rate measured by ECG at Baseline and Week 8 is reported in this outcome measure. | ClinicalTrials.gov |
Outcomes 40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Baseline to follow-up visit (up to approximately 3 years 9 months) | Safety population included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| PRIMARY | Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Day 1 to end of Week 8 | Safety population included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| PRIMARY | Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Day 1 to end of Week 4 | Safety population included all participants received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| PRIMARY | Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment | Week 8 to follow-up visit (up to approximately 3 years 9 months) | Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | 10^9 cells per liter | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158 | Baseline, Week 158 | Safety population included all participants received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | femtoliter (fL) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | 10^12 cells per liter | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | ratio | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | grams per liter (g/L) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | international units per liter (IU/L) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | units per liter (U/L) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | millimoles per liter (mmol/L) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | g/L | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106 | Baseline, Week 106 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | milliliters per minute (mL/min) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158 | Baseline, Week 158 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | micromoles per liter | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Blood Pressure at Week 171 | Baseline, Week 171 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories. | millimeters of mercury (mmHg) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Heart Rate at Week 171 | Baseline, Week 171 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | beats per minute | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Respiration Rate at Week 171 | Baseline, Week 171 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | breaths/minute | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Body Temperature at Week 171 | Baseline, Week 171 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | degrees centigrade | MEAN | ClinicalTrials.gov |
| SECONDARY | Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8 | Baseline, Week 8 | Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | beats/minute | MEAN | ClinicalTrials.gov |
Results by group 279
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Rollover Cohort: SD-809 ER | Any TEAEs | 77 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Switch Cohort: SD-809 ER | Any TEAEs | 35 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Rollover Cohort: SD-809 ER | Serious TEAEs | 21 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Switch Cohort: SD-809 ER | Serious TEAEs | 11 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Rollover Cohort: SD-809 ER | Severe TEAEs | 17 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Switch Cohort: SD-809 ER | Severe TEAEs | 7 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Rollover Cohort: SD-809 ER | Drug-Related TEAEs | 56 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Switch Cohort: SD-809 ER | Drug-Related TEAEs | 26 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Rollover Cohort: SD-809 ER | TEAEs Leading to Withdrawal From Study | 13 | Participants | ClinicalTrials.gov | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period | Switch Cohort: SD-809 ER | TEAEs Leading to Withdrawal From Study | 3 | Participants | ClinicalTrials.gov | |
| Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Rollover Cohort: SD-809 ER | Any TEAEs | 49 | Participants | ClinicalTrials.gov | |
| Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Rollover Cohort: SD-809 ER | Serious TEAEs | 1 | Participants | ClinicalTrials.gov | |
| Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Rollover Cohort: SD-809 ER | Severe TEAEs | 0 | Participants | ClinicalTrials.gov | |
| Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Rollover Cohort: SD-809 ER | Drug-Related TEAEs | 23 | Participants | ClinicalTrials.gov | |
| Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration | Rollover Cohort: SD-809 ER | TEAEs Leading to Withdrawal From Study | 0 | Participants | ClinicalTrials.gov | |
| Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Switch Cohort: SD-809 ER | Any TEAEs | 17 | Participants | ClinicalTrials.gov | |
| Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Switch Cohort: SD-809 ER | Serious TEAEs | 1 | Participants | ClinicalTrials.gov | |
| Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Switch Cohort: SD-809 ER | Severe TEAEs | 1 | Participants | ClinicalTrials.gov | |
| Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Switch Cohort: SD-809 ER | Drug-Related TEAEs | 11 | Participants | ClinicalTrials.gov | |
| Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment | Switch Cohort: SD-809 ER | TEAEs Leading to Withdrawal From Study | 0 | Participants | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Rollover Cohort: SD-809 ER | 82 | ClinicalTrials.gov | |
| Overall Study | STARTED | Switch Cohort: SD-809 ER | 37 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Rollover Cohort: SD-809 ER | 56 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Switch Cohort: SD-809 ER | 25 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Rollover Cohort: SD-809 ER | 26 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Switch Cohort: SD-809 ER | 12 | ClinicalTrials.gov |
Adverse events 184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | Rollover Cohort: SD-809 ER | 0 | 82 | 0 | ClinicalTrials.gov |
| other | Bradycardia | Cardiac disorders | Switch Cohort: SD-809 ER | 2 | 37 | 2 | ClinicalTrials.gov |
| other | Cerumen impaction | Ear and labyrinth disorders | Rollover Cohort: SD-809 ER | 0 | 82 | 0 | ClinicalTrials.gov |
| other | Cerumen impaction | Ear and labyrinth disorders | Switch Cohort: SD-809 ER | 2 | 37 | 2 | ClinicalTrials.gov |
| other | Dry eye | Eye disorders | Rollover Cohort: SD-809 ER | 0 | 82 | 0 | ClinicalTrials.gov |
| other | Dry eye | Eye disorders | Switch Cohort: SD-809 ER | 2 | 37 | 2 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 7 | 82 | 7 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 5 | 37 | 6 | ClinicalTrials.gov |
| other | Diarrhoea | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 11 | 82 | 13 | ClinicalTrials.gov |
| other | Diarrhoea | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 7 | 37 | 11 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 4 | 82 | 4 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 4 | 37 | 4 | ClinicalTrials.gov |
| other | Dysphagia | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 7 | 82 | 12 | ClinicalTrials.gov |
| other | Dysphagia | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 6 | 37 | 7 | ClinicalTrials.gov |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 1 | 82 | 1 | ClinicalTrials.gov |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 2 | 37 | 2 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 8 | 82 | 8 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 3 | 37 | 3 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | Rollover Cohort: SD-809 ER | 7 | 82 | 10 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | Switch Cohort: SD-809 ER | 2 | 37 | 2 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Rollover Cohort: SD-809 ER | 1 | 82 | ClinicalTrials.gov |
| Total, all-cause mortality | Switch Cohort: SD-809 ER | 0 | 37 | ClinicalTrials.gov |
| Total, other adverse events | Rollover Cohort: SD-809 ER | 74 | 82 | ClinicalTrials.gov |
| Total, other adverse events | Switch Cohort: SD-809 ER | 32 | 37 | ClinicalTrials.gov |
| Total, serious adverse events | Rollover Cohort: SD-809 ER | 21 | 82 | ClinicalTrials.gov |
| Total, serious adverse events | Switch Cohort: SD-809 ER | 11 | 37 | ClinicalTrials.gov |
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rollover Cohort: SD-809 ER vs Switch Cohort: SD-809 ER: deaths from any cause | Trial comparisons |
| Rollover Cohort: SD-809 ER vs Switch Cohort: SD-809 ER: serious adverse events | Trial comparisons |
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)