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Clinical Trials/EUCTR2014-001890-15-PL
EUCTR2014-001890-15-PLActive, not recruitingNot Applicable

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA - Aim to Reduce Movements in Tardive Dyskinesia

Auspex Pharmaceuticals, Inc.0 sites92 target enrollmentStarted: August 20, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
92
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 (see Appendix 2), AND
  • •A total motor AIMS score of =6 (based on Items 1 through 7) as assessed by
  • •the Principal Investigator. Note: A video recording of the AIMS assessment
  • •at Screening will 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 have 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 prescribed medications.
  • •8. Subject is able to swallow study drug whole.
  • •9. Subject has provided written, informed consent or, if subject lacks the capacity to
  • •provide informed consent, a legally authorized representative (LAR) has provided
  • •written informed consent and the subject has provided assent.
  • •10. In the opinion of the Investigator, the subject lives in a stable environment, and
  • •has adequate supervision when necessary to comply with all study procedures,
  • •attend all study visits and safely participate in the trial.
  • •11. Subject is in good general health, is expected to attend all study visits and is
  • •expected to complete all study assessments, in the opinion of the Investigator.
  • •12. Subject has sufficient reading skills to comprehend the subject-completed rating
  • •13. Female subjects of childbearing potentiala agree to use one of the following
  • •acceptable methods of contraception from Screening through study completion if
  • •sexually active:
  • •IUD or intrauterine system in place for at least 3 months prior to screening;
  • •Subject or partner using barrier method (e.g., condom, diaphragm, or cervical
  • •cap) with spermicide from Screening through study completion;
  • •Partner has a documented vasectomy >6 months prior to enrollment.
  • •Stable hormonal contraception (with approved oral, transdermal, or depot
  • •regimen) for at least 3 months prior to Screening.
  • •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
  • •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
  • •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
  • •5. Subject has active suicidal ideation at Screening or Baseline.
  • •6. Subject has history of any of the following within 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.
  • •11. Subject has a QTcF value >450 ms (males) or >460 ms (females), or >480 ms
  • •(with right bundle branch block [RBBB]) on 12-lead ECG at Screening.
  • •12. Subject has evidence of hepatic impairment at Screening, as indicated by:
  • •Aspartate transaminase (AST) or alanine aminotransferase (ALT) >2.5 times
  • •the upper limit of normal (ULN).
  • •Alkaline phosphatase (ALP) or total bilirubin (TBil) >2 times the ULN
  • •o Note: Subjects with Gilbert’s Syndrome are eligible to participate if
  • •approved by the Medical Monitor.
  • •o Note: Subjects with abnormalities in two or more of these analytes (AST,
  • •ALT, ALP, TBil) must be approved by the Medical Monitor to be
  • •Prothrombin time >4 seconds prolonged.
  • •Positive Hepatitis B surface antigen (HBsAg).
  • •13. Subject has evidence of significant renal impairment at Screening, indicated by a
  • •creatinine clearance <50 mL/min, as estimated by the Cockroft-Gault formula.
  • •14. Subject has known allergy to tetrabenazine or to any of the components of
  • •15. Subject has participated in an investigational drug or device trial and received
  • •study drug within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
  • •16. Subject is pregnant or breast-feeding at Screening or Baseline.
  • •17. Subject acknowledges present use of illicit drugs at Screening.
  • •18. Subject has a history of alcohol or substance abuse in the previous 12 months, as
  • •defined in the DSM-V, or subject is unable to refrain from substance abuse
  • •throughout the study.
  • •19. Subject has a positive urine drug screen (for amphetamines, barbiturates,
  • •benzodiazepine, phencyclidine, cocaine, or opiates) at Screening or Baseline,
  • •except if subject is receiving a stable dose of a benzodiazepine.

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