Reducing Involuntary Movements in Participants With Tardive Dyskinesia

NCT ID: NCT02198794

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-20
• Study Completion Date: 2020-12-14

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.

Conditions

Tardive Dyskinesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: SD-809

Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.

Group Type: EXPERIMENTAL

SD-809

Intervention Type: DRUG

SD-809 will be administered per dose and schedule specified in the arm.

Part B: Placebo

Participants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks.

Group Type: PLACEBO_COMPARATOR

SD-809

Intervention Type: DRUG

SD-809 will be administered per dose and schedule specified in the arm.

Placebo

Intervention Type: DRUG

Placebo matching to SD-809 will be administered per schedule specified in the arm.

Part B: SD-809

Participants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks.

Group Type: ACTIVE_COMPARATOR

SD-809

Intervention Type: DRUG

SD-809 will be administered per dose and schedule specified in the arm.

Part C: SD-809

EU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B.

Group Type: EXPERIMENTAL

SD-809

Intervention Type: DRUG

SD-809 will be administered per dose and schedule specified in the arm.

Interventions

SD-809

SD-809 will be administered per dose and schedule specified in the arm.

Intervention Type: DRUG

Placebo

Placebo matching to SD-809 will be administered per schedule specified in the arm.

Intervention Type: DRUG

Other Intervention Names

Deutetrabenazine; TEV-50717

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auspex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, M.D.

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 145

Tuscaloosa, Alabama, United States

Teva Investigational Site 107

Anaheim, California, United States

Teva Investigational Site 108

Anaheim, California, United States

Teva Investigational Site 123

Glendale, California, United States

Teva Investigational Site 160

Irvine, California, United States

Teva Investigational Site 176

Loma Linda, California, United States

Teva Investigational Site 121

Los Angeles, California, United States

Teva Investigational Site 147

Los Angeles, California, United States

Teva Investigational Site 174

Norwalk, California, United States

Teva Investigational Site 130

Oceanside, California, United States

Teva Investigational Site 102

Orange, California, United States

Teva Investigational Site 104

San Bernardino, California, United States

Teva Investigational Site 110

San Diego, California, United States

Teva Investigational Site 169

San Rafael, California, United States

Teva Investigational Site 129

Englewood, Colorado, United States

Teva Investigational Site 139

New Haven, Connecticut, United States

Teva Investigational Site 156

Washington D.C., District of Columbia, United States

Teva Investigational Site 157

Boca Raton, Florida, United States

Teva Investigational Site 117

Gainesville, Florida, United States

Teva Investigational Site 150

Lake City, Florida, United States

Teva Investigational Site 153

Miami, Florida, United States

Teva Investigational Site 162

Miami, Florida, United States

Teva Investigational Site 112

Orlando, Florida, United States

Teva Investigational Site 144

Port Charlotte, Florida, United States

Teva Investigational Site 155

Augusta, Georgia, United States

Teva Investigational Site 165

Decatur, Georgia, United States

Teva Investigational Site 131

Chicago, Illinois, United States

Teva Investigational Site 154

Baltimore, Maryland, United States

Teva Investigational Site 101

Glen Burnie, Maryland, United States

Teva Investigational Site 118

Creve Coeur, Missouri, United States

Teva Investigational Site 142

Kansas City, Missouri, United States

Teva Investigational Site 175

St Louis, Missouri, United States

Teva Investigational Site 161

St Louis, Missouri, United States

Teva Investigational Site 178

Lincoln, Nebraska, United States

Teva Investigational Site 128

Albuquerque, New Mexico, United States

Teva Investigational Site 146

Raleigh, North Carolina, United States

Teva Investigational Site 114

Garfield Heights, Ohio, United States

Teva Investigational Site 133

Charleston, South Carolina, United States

Teva Investigational Site 149

Memphis, Tennessee, United States

Teva Investigational Site 151

Fort Worth, Texas, United States

Teva Investigational Site 115

Salt Lake City, Utah, United States

Teva Investigational Site 141

Salt Lake City, Utah, United States

Teva Investigational Site 167

Richland, Washington, United States

Teva Investigational Site 166

Waukesha, Wisconsin, United States

Teva Investigational Site 559

Havířov, , Czechia

Teva Investigational Site 556

Hostivice, , Czechia

Teva Investigational Site 535

Litoměřice, , Czechia

Teva Investigational Site 557

Pilsen, , Czechia

Teva Investigational Site 533

Prague, , Czechia

Teva Investigational Site 530

Prague, , Czechia

Teva Investigational Site 502

Gera, , Germany

Teva Investigational Site 504

Mainz, , Germany

Teva Investigational Site 540

Balassagyarmat, , Hungary

Teva Investigational Site 538

Budapest, , Hungary

Teva Investigational Site 541

Budapest, , Hungary

Teva Investigational Site 539

Doba, , Hungary

Teva Investigational Site 546

Győr, , Hungary

Teva Investigational Site 545

Kalocsa, , Hungary

Teva Investigational Site 514

Bełchatów, , Poland

Teva Investigational Site 554

Bialystok, , Poland

Teva Investigational Site 510

Bydgoszcz, , Poland

Teva Investigational Site 519

Bydgoszcz, , Poland

Teva Investigational Site 536

Bydgoszcz, , Poland

Teva Investigational Site 523

Chełmno, , Poland

Teva Investigational Site 517

Choroszcz, , Poland

Teva Investigational Site 513

Gdansk, , Poland

Teva Investigational Site 512

Katowice, , Poland

Teva Investigational Site 552

Katowice, , Poland

Teva Investigational Site 520

Krakow, , Poland

Teva Investigational Site 509

Krakow, , Poland

Teva Investigational Site 508

Lodz, , Poland

Teva Investigational Site 511

Lublin, , Poland

Teva Investigational Site 524

Lublin, , Poland

Teva Investigational Site 549

Olsztyn, , Poland

Teva Investigational Site 522

Torun, , Poland

Teva Investigational Site 550

Warsaw, , Poland

Teva Investigational Site 516

Wroclaw, , Poland

Teva Investigational Site 529

Bratislava, , Slovakia

Teva Investigational Site 525

Domaša, , Slovakia

Teva Investigational Site 527

Košice, , Slovakia

Teva Investigational Site 528

Rimavská Sobota, , Slovakia

Teva Investigational Site 526

Rožňava, , Slovakia

Countries

United States; Czechia; Germany; Hungary; Poland; Slovakia

References

Frank S, Anderson KE, Fernandez HH, Hauser RA, Claassen DO, Stamler D, Factor SA, Jimenez-Shahed J, Barkay H, Wilhelm A, Alexander JK, Chaijale N, Barash S, Savola JM, Gordon MF, Chen M. Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease. Neurol Ther. 2024 Jun;13(3):655-675. doi: 10.1007/s40120-024-00600-1. Epub 2024 Apr 1.

Reference Type: DERIVED

PMID: 38557959 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31296586 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-001891-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SD-809-C-20

Identifier Type: -

Identifier Source: org_study_id