Adults 18 to 80, any sex, with Tardive Dyskinesia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)Primary· 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 sc
Group
Value
95% CI
Placebo
-1.4
± 0.41
SD-809 12 mg/Day
-2.1
± 0.42
SD-809 24 mg/Day
-3.2
± 0.45
SD-809 36 mg/Day
-3.3
± 0.42
Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)Secondary· 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
Group
Value
95% CI
Placebo
26
16.3 – 38.4
SD-809 12 mg/Day
28
18.5 – 40.8
SD-809 24 mg/Day
49
35.6 – 62.5
SD-809 36 mg/Day
44
31.4 – 56.7
Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12Secondary· 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 c
Group
Value
95% CI
Placebo
-7.1
± 2.06
SD-809 12 mg/Day
-5.8
± 2.03
SD-809 24 mg/Day
-10.2
± 2.21
SD-809 36 mg/Day
-10.7
± 2.04
Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)Secondary· 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
Group
Value
95% CI
Placebo
31
20.6 – 43.8
SD-809 12 mg/Day
23
14.4 – 35.4
SD-809 24 mg/Day
45
31.9 – 58.7
SD-809 36 mg/Day
40
28.1 – 53.2
Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12Secondary· 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 thr
Group
Value
95% CI
Placebo
12
6.0 – 22.9
SD-809 12 mg/Day
13
6.9 – 24.2
SD-809 24 mg/Day
35
22.9 – 48.7
SD-809 36 mg/Day
33
21.8 – 45.9
Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)Secondary· 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 negati
Group
Value
95% CI
Placebo
-11.6
± 4.32
SD-809 12 mg/Day
-20.0
± 4.34
SD-809 24 mg/Day
-31.9
± 4.73
SD-809 36 mg/Day
-33.1
± 4.38
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 PointsSecondary· 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 chang
10% Improvement
Group
Value
95% CI
Placebo
50
37.5 – 62.5
SD-809 12 mg/Day
62
49.0 – 72.9
SD-809 24 mg/Day
67
53.4 – 78.8
SD-809 36 mg/Day
71
57.9 – 81.2
20% Improvement
Group
Value
95% CI
Placebo
40
28.1 – 52.5
SD-809 12 mg/Day
47
34.6 – 59.1
SD-809 24 mg/Day
59
45.2 – 71.8
SD-809 36 mg/Day
60
46.8 – 71.9
30% Improvement
Group
Value
95% CI
Placebo
31
20.6 – 43.8
SD-809 12 mg/Day
32
21.3 – 44.2
SD-809 24 mg/Day
49
35.6 – 62.5
SD-809 36 mg/Day
49
36.4 – 61.9
40% Improvement
Group
Value
95% CI
Placebo
16
8.4 – 26.9
SD-809 12 mg/Day
23
14.4 – 35.4
SD-809 24 mg/Day
45
31.9 – 58.7
SD-809 36 mg/Day
40
28.1 – 53.2
50% Improvement
Group
Value
95% CI
Placebo
12
6.0 – 22.9
SD-809 12 mg/Day
13
6.9 – 24.2
SD-809 24 mg/Day
35
22.9 – 48.7
SD-809 36 mg/Day
33
21.8 – 45.9
60% Improvement
Group
Value
95% CI
Placebo
5
1.8 – 14.1
SD-809 12 mg/Day
7
2.6 – 15.9
SD-809 24 mg/Day
20
11.5 – 33.6
SD-809 36 mg/Day
18
10.2 – 30.3
70% Improvement
Group
Value
95% CI
Placebo
2
0.0 – 9.2
SD-809 12 mg/Day
3
0.4 – 11.5
SD-809 24 mg/Day
12
4.6 – 24.8
SD-809 36 mg/Day
16
7.8 – 28.8
80% Improvement
Group
Value
95% CI
Placebo
2
0.0 – 9.2
SD-809 12 mg/Day
2
0.0 – 8.9
SD-809 24 mg/Day
2
0.1 – 10.9
SD-809 36 mg/Day
13
5.3 – 24.5
Participants With Adverse Events During the Overall Treatment PeriodSecondary· 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
Overall Treatment Period: any AE
Group
Value
95% CI
Placebo
34
SD-809 12 mg/Day
36
SD-809 24 mg/Day
32
SD-809 36 mg/Day
38
Overall Treatment Period: SAE
Group
Value
95% CI
Placebo
4
SD-809 12 mg/Day
2
SD-809 24 mg/Day
6
SD-809 36 mg/Day
4
Overall Treatment Period: Severe AE
Group
Value
95% CI
Placebo
2
SD-809 12 mg/Day
2
SD-809 24 mg/Day
4
SD-809 36 mg/Day
1
Overall Treatment Period: treatment-related AE
Group
Value
95% CI
Placebo
19
SD-809 12 mg/Day
13
SD-809 24 mg/Day
11
SD-809 36 mg/Day
18
Dose reduction because of AE
Group
Value
95% CI
Placebo
0
SD-809 12 mg/Day
0
SD-809 24 mg/Day
1
SD-809 36 mg/Day
3
Dose suspension because of AE
Group
Value
95% CI
Placebo
2
SD-809 12 mg/Day
3
SD-809 24 mg/Day
1
SD-809 36 mg/Day
1
Withdrawn from study because of AE
Group
Value
95% CI
Placebo
2
SD-809 12 mg/Day
4
SD-809 24 mg/Day
2
SD-809 36 mg/Day
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 to Week 12.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 4/72 (6%)
Deaths: 0/72
SD-809 12 mg/Day
Serious: 2/74 (3%)
Deaths: 0/74
SD-809 24 mg/Day
Serious: 6/73 (8%)
Deaths: 1/73
SD-809 36 mg/Day
Serious: 4/74 (5%)
Deaths: 1/74
Serious adverse events (17 terms)
Reaction
System
Placebo
SD-809 12 mg/Day
SD-809 24 mg/Day
SD-809 36 mg/Day
Cardio-respiratory arrest
Cardiac disorders
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
Pancreatic mass
Gastrointestinal disorders
—
—
—
—
Alcohol interaction
General disorders
—
—
—
—
Sudden cardiac death
General disorders
—
—
—
—
Appendicitis
Infections and infestations
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Face injury
Injury, poisoning and procedural complications
—
—
—
—
Head injury
Injury, poisoning and procedural complications
—
—
—
—
Skeletal injury
Injury, poisoning and procedural complications
—
—
—
—
Neuroendocrine carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02198794 — Reducing Involuntary Movements in Participants With Tardive Dyskinesia
· Phase 3
· completed
NCT01897896 — Alternatives for Reducing Chorea in Huntington Disease
· Phase 3
· completed
NCT01795859 — First Time Use of SD-809 in Huntington Disease
· Phase 3
· completed
Other recruiting trials for Tardive Dyskinesia
Currently open trials in the same condition.
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· NA
· recruiting
NCT03495024 — Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
· Phase 4
· recruiting
Other Auspex Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT02198794 — Reducing Involuntary Movements in Participants With Tardive Dyskinesia
· Phase 3
· completed
NCT01897896 — Alternatives for Reducing Chorea in Huntington Disease
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Auspex Pharmaceuticals, Inc.
Last refreshed: 9 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02291861.