Trial · NCT02291861
Addressing Involuntary Movements in Tardive Dyskinesia
NCT02291861, Phase 3, Completed, Auspex Pharmaceuticals, Inc.; results first posted 2018-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Addressing Involuntary Movements in Tardive Dyskinesia. Trials, record NCT02291861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02291861
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Addressing Involuntary Movements in Tardive Dyskinesia
- NCT number
- NCT02291861
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 298 participants, actual
- Lead sponsor
- Auspex Pharmaceuticals, Inc.
- Conditions
- Tardive Dyskinesia
- Interventions
- SD-809, Placebo
- First posted
- 2014-11-17
- Last updated
- 2026-06-23
- Other registries' IDs
- eudract:2014-003135-19
- Results first posted
- 2018-04-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) | Day 0 (Baseline), Weeks 2, 4, 8 and 12 | AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure. |
| Secondary | Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | Week 12 | The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits. |
| Secondary | Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12 | Day 0 (Baseline), Week 12 | The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96. Negative change from baseline scores indicate improvement. For patients with missing data at week 12, the baseline or last available value was used as the week 12 value. |
| Secondary | Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC) | Week 12 | The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits. |
| Secondary | Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12 | Day 0 (Baseline), Week 12 | Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits. AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. |
| Secondary | Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM) | Day 0 (Baseline), Weeks 2, 4, 8 and 12 | AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure. |
| Secondary | Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points | Day 0 (Baseline), Week 12 | AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. Participants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are \< 5, exact Clopper Pearson limits are presented. Data report the percentage of participants who responded to the percentage improvement indicated in each row. |
| Secondary | Participants With Adverse Events During the Overall Treatment Period | Day 1 to Week 12 | An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, 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 patient and required medical intervention to prevent the previously listed serious outcomes. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) | Day 0 (Baseline), Weeks 2, 4, 8 and 12 | The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | Week 12 | The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. | percentage of participants | NUMBER |
| SECONDARY | Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12 | Day 0 (Baseline), Week 12 | The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. One SD-809 12 mg/day participant was missing a baseline mCDQ-24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC) | Week 12 | mITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12 | Day 0 (Baseline), Week 12 | mITT population of participants. Participants with missing Week 12 data were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM) | Day 0 (Baseline), Weeks 2, 4, 8 and 12 | The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included. | percentage of baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points | Day 0 (Baseline), Week 12 | The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. | percentage of participants | NUMBER |
| SECONDARY | Participants With Adverse Events During the Overall Treatment Period | Day 1 to Week 12 | The Safety Population was a subset of randomized participants and included all patients who were administered study drug (N=293). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) | Placebo | -1.4 | Standard Error 0.41 | units on a scale | |
| Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) | SD-809 12 mg/Day | -2.1 | Standard Error 0.42 | units on a scale | |
| Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) | SD-809 24 mg/Day | -3.2 | Standard Error 0.45 | units on a scale | |
| Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM) | SD-809 36 mg/Day | -3.3 | Standard Error 0.42 | units on a scale | |
| Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | Placebo | 26 | 95% Confidence Interval 16.3 to 38.4 | percentage of participants | |
| Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | SD-809 12 mg/Day | 28 | 95% Confidence Interval 18.5 to 40.8 | percentage of participants | |
| Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | SD-809 24 mg/Day | 49 | 95% Confidence Interval 35.6 to 62.5 | percentage of participants | |
| Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | SD-809 36 mg/Day | 44 | 95% Confidence Interval 31.4 to 56.7 | percentage of participants | |
| Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12 | Placebo | -7.1 | Standard Error 2.06 | units on a scale | |
| Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12 | SD-809 12 mg/Day | -5.8 | Standard Error 2.03 | units on a scale |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 74 | |
| Overall Study | STARTED | SD-809 12 mg/Day | 75 | |
| Overall Study | STARTED | SD-809 24 mg/Day | 74 | |
| Overall Study | STARTED | SD-809 36 mg/Day | 75 | |
| Overall Study | Safety Population | Placebo | 72 | |
| Overall Study | Safety Population | SD-809 12 mg/Day | 74 | |
| Overall Study | Safety Population | SD-809 24 mg/Day | 73 | |
| Overall Study | Safety Population | SD-809 36 mg/Day | 74 | |
| Overall Study | Modified Intent to Treat Pop (mITT) | Placebo | 58 | |
| Overall Study | Modified Intent to Treat Pop (mITT) | SD-809 12 mg/Day | 60 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events84
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 |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 72 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | SD-809 12 mg/Day | 1 | 74 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | SD-809 24 mg/Day | 3 | 73 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | SD-809 36 mg/Day | 5 | 74 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 72 | 8 |
| other | Nausea | Gastrointestinal disorders | SD-809 12 mg/Day | 1 | 74 | 1 |
| other | Nausea | Gastrointestinal disorders | SD-809 24 mg/Day | 1 | 73 | 1 |
| other | Nausea | Gastrointestinal disorders | SD-809 36 mg/Day | 1 | 74 | 1 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 72 | 1 |
| other | Nasopharyngitis | Infections and infestations | SD-809 12 mg/Day | 4 | 74 | 4 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 72 |
| Total, all-cause mortality | SD-809 12 mg/Day | 0 | 74 |
| Total, all-cause mortality | SD-809 24 mg/Day | 1 | 73 |
| Total, all-cause mortality | SD-809 36 mg/Day | 1 | 74 |
| Total, other adverse events | Placebo | 14 | 72 |
| Total, other adverse events | SD-809 12 mg/Day | 9 | 74 |
| Total, other adverse events | SD-809 24 mg/Day | 9 | 73 |
| Total, other adverse events | SD-809 36 mg/Day | 10 | 74 |
| Total, serious adverse events | Placebo | 4 | 72 |
| Total, serious adverse events | SD-809 12 mg/Day | 2 | 74 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02291861
GET https://conductscience.org/api/trials/v1/NCT02291861/results?page=2