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Reducing Involuntary Movements in Tardive Dyskinesia (RIM-TD)

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ClinicalTrials.gov Identifier: NCT02198794
Recruitment Status : Active, not recruiting
First Posted : July 24, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Auspex Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following one week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks maintenance with SD-809.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: SD-809 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Actual Study Start Date : October 20, 2014
Estimated Primary Completion Date : November 21, 2020
Estimated Study Completion Date : December 19, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SD-809- Part A
Dose titration for 6 weeks to determine a subject's optimal dose. Subject's dose is then maintained for the duration of the study.
Drug: SD-809
SD-809 tablets dose titrated for 6 weeks until optimal dose is reached. The dose is maintained for the duration of the study.
Other Name: deutetrabenazine
Experimental: SD-809- Part B
I week period of randomized withdrawal
Drug: Placebo
I week period of randomized withdrawal
Experimental: Placebo- Part B
I week period of randomized withdrawal
Drug: Placebo
I week period of randomized withdrawal



Primary Outcome Measures :
  1. Safety [ Time Frame: 159 weeks ]
    Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.


Secondary Outcome Measures :
  1. Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and Week 158 ]
    The change in AIMS score from Baseline of this study at each visit that this is measured, as assessed by blinded central video rating to Week 158.

  2. Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and Week 158 ]
    The change in AIMS score from Baseline of this study at each visit that this is measured, as assessed by the site rating to Week 159.

  3. Quality of Life Exploratory Efficacy Assessment [ Time Frame: Baseline through Week 158 ]
    Quality of Life

  4. PGIC Exploratory Efficacy Assessment [ Time Frame: Baseline through Week 158 ]
    Treatment success based on the Patient Global Impression of Change (PGIC)

  5. AIMS Exploratory Efficacy Assessment [ Time Frame: Baseline through Week 158 ]
    Percent change in AIMS score

  6. AIMS responders Exploratory Efficacy Assessment [ Time Frame: Baseline through Week 158 ]
    Proportion of responders based on AIMS change from baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of using a dopamine receptor antagonist for at least 3 months
  • Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
  • Subject has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia
  • Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
  • Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
  • History of being compliant with prescribed medications
  • Able to swallow study drug whole
  • Be in good general health and is expected to attend all study visits and complete study assessments
  • Female subjects must not be pregnant and agree to an acceptable method of contraception

Exclusion Criteria:

  • Currently receiving medication for the treatment of tardive dyskinesia
  • Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
  • Have a serious untreated or undertreated psychiatric illness
  • Have recent history or presence of violent behavior
  • Have unstable or serious medical illness
  • Have evidence of hepatic impairment
  • Have evidence of renal impairment
  • Have known allergy to any component of SD-809 or tetrabenazine
  • Has participated in an investigational drug or device trial and received study drug within 30 days
  • Have acknowledged use of illicit drugs
  • Have a history of alcohol or substance abuse in the previous 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198794


  Show 82 Study Locations
Sponsors and Collaborators
Auspex Pharmaceuticals, Inc.
Investigators
Study Director: Teva Medical Expert, M.D. TEVA

Responsible Party: Auspex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02198794     History of Changes
Other Study ID Numbers: SD-809-C-20
2014-001891-73 ( EudraCT Number )
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teva Pharmaceutical Industries ( Auspex Pharmaceuticals, Inc. ):
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced