Trial · NCT02198794
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
NCT02198794, Phase 3, Completed, Auspex Pharmaceuticals, Inc.; results first posted 2021-03-01
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ConductScience Library. Reducing Involuntary Movements in Participants With Tardive Dyskinesia. Trials, record NCT02198794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02198794
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reducing Involuntary Movements in Participants With Tardive Dyskinesia
- NCT number
- NCT02198794
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 343 participants, actual
- Lead sponsor
- Auspex Pharmaceuticals, Inc.
- Conditions
- Tardive Dyskinesia
- Interventions
- SD-809, Placebo
- First posted
- 2014-07-24
- Last updated
- 2022-04-01
- Other registries' IDs
- eudract:2014-001891-73
- Results first posted
- 2021-03-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days) | AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite 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. A treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Primary | Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating | Day 1 of Part B, Day 7 of Part B | The 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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | Baseline, Week 145 | The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | Baseline, Week 158 | The 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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | Baseline, Week 145 | The 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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | Baseline, Week 158 | The 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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | Baseline to Week 145 | The 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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | Baseline to Week 145 | The 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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
| Secondary | Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating | Baseline, Week 145 | The 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. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease. |
| Secondary | Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC) | Baseline up to Week 145 | A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days) | Safety population included all participants who were administered any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating | Day 1 of Part B, Day 7 of Part B | The randomized withdrawal modified intent-to-treat (mITT) population included all participants enrolled in Part B who received study drug during the randomized withdrawal period and had a total motor AIMS score as assessed by blinded central video rating at both the pre-withdrawal visit and the post-withdrawal visit. | units on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | Baseline, Week 145 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | Baseline, Week 158 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | Baseline, Week 145 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | Baseline, Week 158 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | Baseline to Week 145 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | Baseline to Week 145 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating | Baseline, Week 145 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC) | Baseline up to Week 145 | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | SD-809 | Any TEAEs | 269 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Part C: SD-809 | Any TEAEs | 23 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | SD-809 | Serious TEAEs | 68 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Part C: SD-809 | Serious TEAEs | 5 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | SD-809 | Severe TEAEs | 57 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Part C: SD-809 | Severe TEAEs | 3 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | SD-809 | Drug-Related TEAEs | 154 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Part C: SD-809 | Drug-Related TEAEs | 3 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | SD-809 | TEAEs Leading to Withdrawal From Study | 42 | Participants | |
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | Part C: SD-809 | TEAEs Leading to Withdrawal From Study | 3 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: Open-Label (158 Weeks) | STARTED | SD-809 | 337 | |
| Part A: Open-Label (158 Weeks) | STARTED | Part B: Placebo | 0 | |
| Part A: Open-Label (158 Weeks) | STARTED | Part B: SD-809 | 0 | |
| Part A: Open-Label (158 Weeks) | STARTED | Part C: SD-809 | 0 | |
| Part A: Open-Label (158 Weeks) | Received at Least 1 Dose of Study Drug | SD-809 | 337 | |
| Part A: Open-Label (158 Weeks) | Received at Least 1 Dose of Study Drug | Part B: Placebo | 0 | |
| Part A: Open-Label (158 Weeks) | Received at Least 1 Dose of Study Drug | Part B: SD-809 | 0 | |
| Part A: Open-Label (158 Weeks) | Received at Least 1 Dose of Study Drug | Part C: SD-809 | 0 | |
| Part A: Open-Label (158 Weeks) | Intent-to-Treat (ITT) Population | SD-809 | 337 | |
| Part A: Open-Label (158 Weeks) | Intent-to-Treat (ITT) Population | Part B: Placebo | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events192
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 | Part A and Part B Participants | 27 | 337 | 32 |
| other | Diarrhoea | Gastrointestinal disorders | Part C: SD-809 | 0 | 80 | 0 |
| other | Nasopharyngitis | Infections and infestations | Part A and Part B Participants | 20 | 337 | 28 |
| other | Nasopharyngitis | Infections and infestations | Part C: SD-809 | 2 | 80 | 2 |
| other | Urinary tract infection | Infections and infestations | Part A and Part B Participants | 31 | 337 | 56 |
| other | Urinary tract infection | Infections and infestations | Part C: SD-809 | 0 | 80 | 0 |
| other | Fall | Injury, poisoning and procedural complications | Part A and Part B Participants | 18 | 337 | 23 |
| other | Fall | Injury, poisoning and procedural complications | Part C: SD-809 | 0 | 80 | 0 |
| other | Weight decreased | Investigations | Part A and Part B Participants | 32 | 337 | 34 |
| other | Weight decreased | Investigations | Part C: SD-809 | 0 | 80 | 0 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A and Part B Participants | 8 | 337 |
| Total, all-cause mortality | Part C: SD-809 | 2 | 80 |
| Total, other adverse events | Part A and Part B Participants | 172 | 337 |
| Total, other adverse events | Part C: SD-809 | 5 | 80 |
| Total, serious adverse events | Part A and Part B Participants | 68 | 337 |
| Total, serious adverse events | Part C: SD-809 | 5 | 80 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A and Part B Participants vs Part C: SD-809: deaths from any cause | Trial comparisons |
| Part A and Part B Participants vs Part C: SD-809: 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/NCT02198794
GET https://conductscience.org/api/trials/v1/NCT02198794/results?page=2