Clinical trial NCT02198794: Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Official title: An Open-Label, Long-Term Safety 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: 2014-07-24
Enrollment: 343
Sex: ALL
Minimum age (years): 18
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 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 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.

Detailed description: Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C.

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
* Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia
* Participants 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 participants 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 (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) 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: Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal
timeFrame: Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)
measure: Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating
timeFrame: Day 1 of Part B, Day 7 of Part B
Secondary outcomes:
measure: Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
timeFrame: Baseline, Week 145
measure: Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating
timeFrame: Baseline, Week 158
measure: Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
timeFrame: Baseline, Week 145
measure: Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating
timeFrame: Baseline, Week 158
measure: Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating
timeFrame: Baseline to Week 145
measure: Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating
timeFrame: Baseline to Week 145
measure: Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating
timeFrame: Baseline, Week 145
measure: Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC)
timeFrame: Baseline up to Week 145
measure: Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC)
timeFrame: Baseline up to Week 145
measure: Part A: Change From Baseline in Modified CDQ-24 Score at Week 158
timeFrame: Baseline, Week 158
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: Irvine
country: United States
facility: Teva Investigational Site 160
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 130
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: 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: 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: Raleigh
country: United States
facility: Teva Investigational Site 146
state: North Carolina
city: Garfield Heights
country: United States
facility: Teva Investigational Site 114
state: Ohio
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: 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: Litomerice
country: Czechia
facility: Teva Investigational Site 535
city: Plzen
country: Czechia
facility: Teva Investigational Site 557
city: Prague 10
country: Czechia
facility: Teva Investigational Site 533
city: Prague 6
country: Czechia
facility: Teva Investigational Site 530
city: Gera
country: Germany
facility: Teva Investigational Site 502
city: Mainz
country: Germany
facility: Teva Investigational Site 504
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: 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: 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 524
city: Olsztyn
country: Poland
facility: Teva Investigational Site 549
city: Torun
country: Poland
facility: Teva Investigational Site 522
city: Warszawa
country: Poland
facility: Teva Investigational Site 550
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, M.D.
role: STUDY_DIRECTOR
References:
citation: Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10.