Clinical trial NCT02195700: Aim to Reduce Movements in Tardive Dyskinesia
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tardive Dyskinesia
Keywords: Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.


Eligibility 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
* 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

Primary outcomes:
measure: Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
timeFrame: Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
Secondary outcomes:
measure: Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)
timeFrame: Week 12
measure: Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)
timeFrame: Week 12
measure: Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24)
timeFrame: Day 0 (Baseline), Week 12 with last observation carried forward
measure: Participants With Adverse Events for the Overall Treatment Period
timeFrame: Day 1 to Week 12
measure: Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis
timeFrame: Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
measure: Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12
timeFrame: Day 0 (Baseline), Week 12
measure: Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis
timeFrame: Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Glendale
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Lake City
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Asheville
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Prague
country: Czechia
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Torun
country: Poland
city: Hronovce
country: Slovakia
city: Roznava
country: Slovakia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, M.D.
role: STUDY_DIRECTOR
References: