A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA

Phase 1

• Conditions: Tardive Dyskinesia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001890-15-CZ
• Lead Sponsor: Auspex Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-14
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Subject is between 18 and 75 years of age, inclusive.
2. Subject has a history of using a dopamine receptor antagonist for at least 3 months (or 1 month in subjects 60 years of age and older).
3. Subject has a clinical diagnosis of TD and has had symptoms for at least 3 months prior to Screening.
4. The subject's TD symptoms are bothersome to the subject or cause functional impairment.
5. At the Screening and Baseline visits, the subject has:
• Moderate or severe abnormal movements as judged by the Investigator based on Item 8 of the AIMS, AND
• A total motor AIMS score of = 6 (based on Items 1 through 7) as assessed by the Investigator.
Note: A video recording of the AIMS at Screening will also be reviewed by a blinded central rater to confirm eligibility prior to randomization.
6. For subjects with underlying psychiatric illness:
• Subject is psychiatrically stable and has had no change in psychoactive medications (including, but not limited to, neuroleptics, benzodiazepines, anticonvulsants, and mood stabilizers) for = 30 days before Screening (45 days for antidepressants).
• Subjects on long-acting (depot) medications been on stable therapy (dose, frequency) for =3 months before Screening.
• Subject has a mental health provider who is aware of the subject's participation in the trial, and does not anticipate any changes to the subject's treatment regimen (drug, dose, frequency) in the next 3 months.
7. Subject has a history of being compliant with medications.
8. Subject is able to swallow study drug whole.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 73
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

1. Subject has received any of the following medications within 30 days of Screening or
Baseline:
• Tetrabenazine, reserpine, a-methyl-p-tyrosine (AMPT), botulinum toxin (within 3 months of Screening), and medications with strong anticholinergic activity (trihexyphenidyl, benztropine, orphenadrine, procyclidine, and biperiden)
• Metoclopramide, promethazine, and prochlorperazine
• Stimulants (i.e., methylphenidate, amphetamine/dextroamphetamine, lisdexamphetamine, etc.), or monoamine oxidase inhibitors (MAOIs)
• Levodopa or dopamine agonists
2. Subject has participated in any previous study of SD-809 in which they received SD-809.
3. Subject has a neurological condition other than TD that may interfere with assessing the severity of dyskinesias.
4. Subject has a serious untreated or undertreated psychiatric illness at Screening or Baseline.
5. Subject has active suicidal ideation at Screening or Baseline.
6. Subject has history of any of the following within the last 6 months of Screening:
• Previous intent to act on suicidal ideation with a specific plan (positive answer to question 5 on C-SSRS), irrespective of level of ambivalence at the time of suicidal thought
• Previous preparatory acts to commit suicide or suicidal behavior
• A previous actual, interrupted or aborted suicide attempt
7. Subject has a score =11 on the depression subscale of the Hospital Anxiety and Depression Scale (HADS) at Screening or Baseline.
8. Subject is developmentally disabled or has evidence of dementia.
9. Subject has an unstable or serious medical illness at Screening or Baseline.
10. Subject has history (within 3 months) or presence of violent behavior.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified