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Addressing Involuntary Movements in Tardive Dyskinesia

NCT ID: NCT02291861

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-08-19

Brief Summary

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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.

Detailed Description

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Conditions

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Tardive Dyskinesia

Keywords

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Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo tablets taken twice daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.

SD-809 12 mg/day

SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.

Group Type EXPERIMENTAL

SD-809

Intervention Type DRUG

SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.

SD-809 24 mg/day

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.

Group Type EXPERIMENTAL

SD-809

Intervention Type DRUG

SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.

SD-809 36 mg/day

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.

Group Type EXPERIMENTAL

SD-809

Intervention Type DRUG

SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.

Interventions

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SD-809

SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.

Intervention Type DRUG

Placebo

Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.

Intervention Type DRUG

Other Intervention Names

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deutetrabenzine Austedo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Auspex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 145

Tuscaloosa, Alabama, United States

Site Status

Teva Investigational Site 107

Anaheim, California, United States

Site Status

Teva Investigational Site 108

Anaheim, California, United States

Site Status

Teva Investigational Site 123

Glendale, California, United States

Site Status

Teva Investigational Site 177

Imperial, California, United States

Site Status

Teva Investigational Site 160

Irvine, California, United States

Site Status

Teva Investigational Site 106

Irvine, California, United States

Site Status

Teva Investigational Site 176

Loma Linda, California, United States

Site Status

Teva Investigational Site 121

Los Angeles, California, United States

Site Status

Teva Investigational Site 147

Los Angeles, California, United States

Site Status

Teva Investigational Site 174

Norwalk, California, United States

Site Status

Teva Investigational Site 170

Oceanside, California, United States

Site Status

Teva Investigational Site 102

Orange, California, United States

Site Status

Teva Investigational Site 104

San Bernardino, California, United States

Site Status

Teva Investigational Site 110

San Diego, California, United States

Site Status

Teva Investigational Site 169

San Rafael, California, United States

Site Status

Teva Investigational Site 129

Englewood, Colorado, United States

Site Status

Teva Investigational Site 139

New Haven, Connecticut, United States

Site Status

Teva Investigational Site 156

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

Site Status

Teva Investigational Site 157

Boca Raton, Florida, United States

Site Status

Teva Investigational Site 117

Gainesville, Florida, United States

Site Status

Teva Investigational Site 150

Lake City, Florida, United States

Site Status

Teva Investigational Site 153

Miami, Florida, United States

Site Status

Teva Investigational Site 162

Miami, Florida, United States

Site Status

Teva Investigational Site 112

Orlando, Florida, United States

Site Status

Teva Investigational Site 144

Port Charlotte, Florida, United States

Site Status

Teva Investigational Site 155

Augusta, Georgia, United States

Site Status

Teva Investigational Site 165

Decatur, Georgia, United States

Site Status

Teva Investigational Site 131

Chicago, Illinois, United States

Site Status

Teva Investigational Site 113

Chicago, Illinois, United States

Site Status

Teva Investigational Site 164

Kansas City, Kansas, United States

Site Status

Teva Investigational Site 154

Baltimore, Maryland, United States

Site Status

Teva Investigational Site 101

Glen Burnie, Maryland, United States

Site Status

Teva Investigational Site 135

Boston, Massachusetts, United States

Site Status

Teva Investigational Site 118

Creve Coeur, Missouri, United States

Site Status

Teva Investigational Site 142

Kansas City, Missouri, United States

Site Status

Teva Investigational Site 175

St Louis, Missouri, United States

Site Status

Teva Investigational Site 161

St Louis, Missouri, United States

Site Status

Teva Investigational Site 178

Lincoln, Nebraska, United States

Site Status

Teva Investigational Site 128

Albuquerque, New Mexico, United States

Site Status

Teva Investigational Site 172

Commack, New York, United States

Site Status

Teva Investigational Site 148

New York, New York, United States

Site Status

Teva Investigational Site 138

Asheville, North Carolina, United States

Site Status

Teva Investigational Site 146

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 133

Charleston, South Carolina, United States

Site Status

Teva Investigational Site 149

Memphis, Tennessee, United States

Site Status

Teva Investigational Site 151

Fort Worth, Texas, United States

Site Status

Teva Investigational Site 115

Salt Lake City, Utah, United States

Site Status

Teva Investigational Site 141

Salt Lake City, Utah, United States

Site Status

Teva Investigational Site 168

Burlington, Vermont, United States

Site Status

Teva Investigational Site 171

Charlottesville, Virginia, United States

Site Status

Teva Investigational Site 167

Richland, Washington, United States

Site Status

Teva Investigational Site 166

Waukesha, Wisconsin, United States

Site Status

Teva Investigational Site 559

Havířov, , Czechia

Site Status

Teva Investigational Site 556

Hostivice, , Czechia

Site Status

Teva Investigational Site 558

Hradec Králové, , Czechia

Site Status

Teva Investigational Site 535

Litoměřice, , Czechia

Site Status

Teva Investigational Site 557

Pilsen, , Czechia

Site Status

Teva Investigational Site 533

Prague, , Czechia

Site Status

Teva Investigational Site 532

Prague, , Czechia

Site Status

Teva Investigational Site 530

Prague, , Czechia

Site Status

Teva Investigational Site 531

Prague, , Czechia

Site Status

Teva Investigational Site 534

Prague, , Czechia

Site Status

Teva Investigational Site 502

Gera, , Germany

Site Status

Teva Investigational Site 503

Haag in Oberbayern, , Germany

Site Status

Teva Investigational Site 504

Mainz, , Germany

Site Status

Teva Investigational Site 507

Prien am Chiemsee, , Germany

Site Status

Teva Investigational Site 544

Taufkirchen, , Germany

Site Status

Teva Investigational Site 501

Wolfach, , Germany

Site Status

Teva Investigational Site 540

Balassagyarmat, , Hungary

Site Status

Teva Investigational Site 538

Budapest, , Hungary

Site Status

Teva Investigational Site 541

Budapest, , Hungary

Site Status

Teva Investigational Site 537

Budapest, , Hungary

Site Status

Teva Investigational Site 542

Budapest, , Hungary

Site Status

Teva Investigational Site 539

Doba, , Hungary

Site Status

Teva Investigational Site 546

Győr, , Hungary

Site Status

Teva Investigational Site 545

Kalocsa, , Hungary

Site Status

Teva Investigational Site 547

Szeged, , Hungary

Site Status

Teva Investigational Site 514

Bełchatów, , Poland

Site Status

Teva Investigational Site 554

Bialystok, , Poland

Site Status

Teva Investigational Site 510

Bydgoszcz, , Poland

Site Status

Teva Investigational Site 519

Bydgoszcz, , Poland

Site Status

Teva Investigational Site 536

Bydgoszcz, , Poland

Site Status

Teva Investigational Site 523

Chełmno, , Poland

Site Status

Teva Investigational Site 517

Choroszcz, , Poland

Site Status

Teva Investigational Site 513

Gdansk, , Poland

Site Status

Teva Investigational Site 512

Katowice, , Poland

Site Status

Teva Investigational Site 552

Katowice, , Poland

Site Status

Teva Investigational Site 520

Krakow, , Poland

Site Status

Teva Investigational Site 509

Krakow, , Poland

Site Status

Teva Investigational Site 508

Lodz, , Poland

Site Status

Teva Investigational Site 511

Lublin, , Poland

Site Status

Teva Investigational Site 515

Lublin, , Poland

Site Status

Teva Investigational Site 524

Lublin, , Poland

Site Status

Teva Investigational Site 549

Olsztyn, , Poland

Site Status

Teva Investigational Site 521

Pruszków, , Poland

Site Status

Teva Investigational Site 518

Sosnowiec, , Poland

Site Status

Teva Investigational Site 522

Torun, , Poland

Site Status

Teva Investigational Site 550

Warsaw, , Poland

Site Status

Teva Investigational Site 555

Warsaw, , Poland

Site Status

Teva Investigational Site 516

Wroclaw, , Poland

Site Status

Teva Investigational Site 529

Bratislava, , Slovakia

Site Status

Teva Investigational Site 525

Domaša, , Slovakia

Site Status

Teva Investigational Site 527

Košice, , Slovakia

Site Status

Teva Investigational Site 528

Rimavská Sobota, , Slovakia

Site Status

Teva Investigational Site 526

Rožňava, , Slovakia

Site Status

Countries

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United States Czechia Germany Hungary Poland Slovakia

References

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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.

Reference Type RESULT
PMID: 28668671 (View on PubMed)

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)

Other Identifiers

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2014-003135-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SD-809-C-23

Identifier Type: -

Identifier Source: org_study_id