Trial · NCT02195700
Aim to Reduce Movements in Tardive Dyskinesia
NCT02195700, Phase 2, Phase 3, Completed, Auspex Pharmaceuticals, Inc.; results first posted 2018-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aim to Reduce Movements in Tardive Dyskinesia. Trials, record NCT02195700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195700
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aim to Reduce Movements in Tardive Dyskinesia
- NCT number
- NCT02195700
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- Auspex Pharmaceuticals, Inc.
- Conditions
- Tardive Dyskinesia
- Interventions
- SD-809, Placebo
- First posted
- 2014-07-21
- Last updated
- 2021-11-09
- Results first posted
- 2018-03-20
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 Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis | Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12 | AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS 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, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement. A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point, treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. An unstructured covariance model was used. |
| Secondary | Percentage of Patients Who Are 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. |
| Secondary | Percentage of Patients Who Are 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. |
| Secondary | Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24) | Day 0 (Baseline), Week 12 with last observation carried forward | 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 CDQ-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 (no impairment) to 96 (severe impairment). Negative change from baseline scores indicate improvement. |
| Secondary | Participants With Adverse Events for 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. |
| Secondary | Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis | Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12 | AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS 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, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative percent change from baseline score indicates improvement. The MMRM model includes fixed effects for treatment, time point (weeks 2, 4, 6, 9, 12), treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. Patient is a random effect. |
| Secondary | Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12 | Day 0 (Baseline), Week 12 | Response level represents the % improvement in AIMS from baseline. AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS 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, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). Patients with a missing AIMS score were considered to be AIMS nonresponders. |
| Secondary | Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis | Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12 | This outcome is similar to the primary outcome except that AIMS was read locally. AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. This outcome reports the local reading of AIMS data. This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement. A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point (weeks 2, 4, 6, 9, and 12), treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. |
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 Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis | Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12 | The Modified ITT (mITT) Population was defined as all patients in the ITT Population who received study drug and had at least 1 centrally read post-baseline assessment of the AIMS from at least 1 scheduled post-baseline time point. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | Week 12 | modified intent to treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC) | Week 12 | modified intent to treat population | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24) | Day 0 (Baseline), Week 12 with last observation carried forward | modified intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Participants With Adverse Events for the Overall Treatment Period | Day 1 to Week 12 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis | Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12 | modified intent to treat population. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12 | Day 0 (Baseline), Week 12 | modified intent to treat population. | percentage of participants | NUMBER |
| SECONDARY | Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis | Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12 | modified intent to treat analysis. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis | SD-809 | -3.0 | Standard Error 0.45 | units on a scale | |
| Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis | Placebo | -1.6 | Standard Error 0.46 | units on a scale | |
| Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | SD-809 | 48.2 | percentage of participants | ||
| Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC) | Placebo | 40.4 | percentage of participants | ||
| Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC) | SD-809 | 42.9 | percentage of participants | ||
| Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC) | Placebo | 29.8 | percentage of participants | ||
| Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24) | SD-809 | -11.1 | Standard Error 2.14 | units on a scale | |
| Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24) | Placebo | -8.3 | Standard Error 2.31 | units on a scale | |
| Participants With Adverse Events for the Overall Treatment Period | SD-809 | Overall Treatment Period: any AE | 41 | Participants | |
| Participants With Adverse Events for the Overall Treatment Period | Placebo | Overall Treatment Period: any AE | 36 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SD-809 | 58 | |
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | Safety and ITT Populations | SD-809 | 58 | |
| Overall Study | Safety and ITT Populations | Placebo | 59 | |
| Overall Study | Modified ITT Population | SD-809 | 56 | |
| Overall Study | Modified ITT Population | Placebo | 57 | |
| Overall Study | Maintenance Period | SD-809 | 53 | |
| Overall Study | Maintenance Period | Placebo | 54 | |
| Overall Study | COMPLETED | SD-809 | 52 | |
| Overall Study | COMPLETED | Placebo | 52 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events38
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 | Dry mouth | Gastrointestinal disorders | SD-809 | 2 | 58 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 59 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | SD-809 | 3 | 58 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 59 | 4 |
| other | Vomiting | Gastrointestinal disorders | SD-809 | 1 | 58 | 1 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 59 | 3 |
| other | Fatigue | General disorders | SD-809 | 4 | 58 | 4 |
| other | Fatigue | General disorders | Placebo | 5 | 59 | 6 |
| other | Upper respiratory tract infection | Infections and infestations | SD-809 | 2 | 58 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 3 | 59 | 3 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SD-809 | 0 | 58 |
| Total, all-cause mortality | Placebo | 0 | 59 |
| Total, other adverse events | SD-809 | 24 | 58 |
| Total, other adverse events | Placebo | 26 | 59 |
| Total, serious adverse events | SD-809 | 3 | 58 |
| Total, serious adverse events | Placebo | 5 | 59 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38557959 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SD-809 vs Placebo: deaths from any cause | Trial comparisons |
| SD-809 vs Placebo: serious adverse events | Trial comparisons |
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/NCT02195700
GET https://conductscience.org/api/trials/v1/NCT02195700/results?page=2