Clinical trial NCT02291861: Addressing Involuntary Movements in Tardive Dyskinesia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: 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: 2014-11-17
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 fixed-doses of 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 must agree to an acceptable method of contraception throughout the study

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 or device 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 Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)
timeFrame: Day 0 (Baseline), Weeks 2, 4, 8 and 12
Secondary outcomes:
measure: Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)
timeFrame: Week 12
measure: Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12
timeFrame: Day 0 (Baseline), Week 12
measure: Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)
timeFrame: Week 12
measure: Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12
timeFrame: Day 0 (Baseline), Week 12
measure: Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Day 0 (Baseline), Weeks 2, 4, 8 and 12
measure: 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 Points
timeFrame: Day 0 (Baseline), Week 12
measure: Participants With Adverse Events During the Overall Treatment Period
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Teva Investigational Site 145
state: Alabama
city: Anaheim
country: United States
facility: Teva Investigational Site 107
state: California
city: Anaheim
country: United States
facility: Teva Investigational Site 108
state: California
city: Glendale
country: United States
facility: Teva Investigational Site 123
state: California
city: Imperial
country: United States
facility: Teva Investigational Site 177
state: California
city: Irvine
country: United States
facility: Teva Investigational Site 160
state: California
city: Irvine
country: United States
facility: Teva Investigational Site 106
state: California
city: Loma Linda
country: United States
facility: Teva Investigational Site 176
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 121
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 147
state: California
city: Norwalk
country: United States
facility: Teva Investigational Site 174
state: California
city: Oceanside
country: United States
facility: Teva Investigational Site 170
state: California
city: Orange
country: United States
facility: Teva Investigational Site 102
state: California
city: San Bernardino
country: United States
facility: Teva Investigational Site 104
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 110
state: California
city: San Rafael
country: United States
facility: Teva Investigational Site 169
state: California
city: Englewood
country: United States
facility: Teva Investigational Site 129
state: Colorado
city: New Haven
country: United States
facility: Teva Investigational Site 139
state: Connecticut
city: Washington
country: United States
facility: Teva Investigational Site 156
state: District of Columbia
city: Boca Raton
country: United States
facility: Teva Investigational Site 157
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 117
state: Florida
city: Lake City
country: United States
facility: Teva Investigational Site 150
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 153
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 162
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 112
state: Florida
city: Port Charlotte
country: United States
facility: Teva Investigational Site 144
state: Florida
city: Augusta
country: United States
facility: Teva Investigational Site 155
state: Georgia
city: Decatur
country: United States
facility: Teva Investigational Site 165
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 131
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 113
state: Illinois
city: Kansas City
country: United States
facility: Teva Investigational Site 164
state: Kansas
city: Baltimore
country: United States
facility: Teva Investigational Site 154
state: Maryland
city: Glen Burnie
country: United States
facility: Teva Investigational Site 101
state: Maryland
city: Boston
country: United States
facility: Teva Investigational Site 135
state: Massachusetts
city: Creve Coeur
country: United States
facility: Teva Investigational Site 118
state: Missouri
city: Kansas City
country: United States
facility: Teva Investigational Site 142
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 175
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 161
state: Missouri
city: Lincoln
country: United States
facility: Teva Investigational Site 178
state: Nebraska
city: Albuquerque
country: United States
facility: Teva Investigational Site 128
state: New Mexico
city: Commack
country: United States
facility: Teva Investigational Site 172
state: New York
city: New York
country: United States
facility: Teva Investigational Site 148
state: New York
city: Asheville
country: United States
facility: Teva Investigational Site 138
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 146
state: North Carolina
city: Charleston
country: United States
facility: Teva Investigational Site 133
state: South Carolina
city: Memphis
country: United States
facility: Teva Investigational Site 149
state: Tennessee
city: Fort Worth
country: United States
facility: Teva Investigational Site 151
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 115
state: Utah
city: Salt Lake City
country: United States
facility: Teva Investigational Site 141
state: Utah
city: Burlington
country: United States
facility: Teva Investigational Site 168
state: Vermont
city: Charlottesville
country: United States
facility: Teva Investigational Site 171
state: Virginia
city: Richland
country: United States
facility: Teva Investigational Site 167
state: Washington
city: Waukesha
country: United States
facility: Teva Investigational Site 166
state: Wisconsin
city: Havirov
country: Czechia
facility: Teva Investigational Site 559
city: Hostivice
country: Czechia
facility: Teva Investigational Site 556
city: Hradec Kralove
country: Czechia
facility: Teva Investigational Site 558
city: Litomerice
country: Czechia
facility: Teva Investigational Site 535
city: Plzen
country: Czechia
facility: Teva Investigational Site 557
city: Prague 6
country: Czechia
facility: Teva Investigational Site 530
city: Prague 8
country: Czechia
facility: Teva Investigational Site 531
city: Praha 10
country: Czechia
facility: Teva Investigational Site 533
city: Praha 5
country: Czechia
facility: Teva Investigational Site 532
city: Praha 9
country: Czechia
facility: Teva Investigational Site 534
city: Gera
country: Germany
facility: Teva Investigational Site 502
city: Haag In Oberbayern
country: Germany
facility: Teva Investigational Site 503
city: Mainz
country: Germany
facility: Teva Investigational Site 504
city: Prien am Chiemsee
country: Germany
facility: Teva Investigational Site 507
city: Taufkirchen
country: Germany
facility: Teva Investigational Site 544
city: Wolfach
country: Germany
facility: Teva Investigational Site 501
city: Balassagyarmat
country: Hungary
facility: Teva Investigational Site 540
city: Budapest
country: Hungary
facility: Teva Investigational Site 538
city: Budapest
country: Hungary
facility: Teva Investigational Site 541
city: Budapest
country: Hungary
facility: Teva Investigational Site 537
city: Budapest
country: Hungary
facility: Teva Investigational Site 542
city: Doba
country: Hungary
facility: Teva Investigational Site 539
city: Gyor
country: Hungary
facility: Teva Investigational Site 546
city: Kalocsa
country: Hungary
facility: Teva Investigational Site 545
city: Szeged
country: Hungary
facility: Teva Investigational Site 547
city: Belchatow
country: Poland
facility: Teva Investigational Site 514
city: Bialystok
country: Poland
facility: Teva Investigational Site 554
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 510
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 519
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 536
city: Chelmno
country: Poland
facility: Teva Investigational Site 523
city: Choroszcz
country: Poland
facility: Teva Investigational Site 517
city: Gdansk
country: Poland
facility: Teva Investigational Site 513
city: Katowice
country: Poland
facility: Teva Investigational Site 512
city: Katowice
country: Poland
facility: Teva Investigational Site 552
city: Krakow
country: Poland
facility: Teva Investigational Site 520
city: Krakow
country: Poland
facility: Teva Investigational Site 509
city: Lodz
country: Poland
facility: Teva Investigational Site 508
city: Lublin
country: Poland
facility: Teva Investigational Site 511
city: Lublin
country: Poland
facility: Teva Investigational Site 515
city: Lublin
country: Poland
facility: Teva Investigational Site 524
city: Olsztyn
country: Poland
facility: Teva Investigational Site 549
city: Pruszkow
country: Poland
facility: Teva Investigational Site 521
city: Sosnowiec
country: Poland
facility: Teva Investigational Site 518
city: Torun
country: Poland
facility: Teva Investigational Site 522
city: Warszawa
country: Poland
facility: Teva Investigational Site 550
city: Warszawa
country: Poland
facility: Teva Investigational Site 555
city: Wroclaw
country: Poland
facility: Teva Investigational Site 516
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 529
city: Hronovce
country: Slovakia
facility: Teva Investigational Site 525
city: Kosice
country: Slovakia
facility: Teva Investigational Site 527
city: Rimavska Sobota
country: Slovakia
facility: Teva Investigational Site 528
city: Roznava
country: Slovakia
facility: Teva Investigational Site 526
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojarvi J, Jarskog LF, Jimenez-Shahed J, Kumar R, McEvoy JP, Ochudlo S, Ondo WG, Fernandez HH. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017 Aug;4(8):595-604. doi: 10.1016/S2215-0366(17)30236-5. Epub 2017 Jun 28.