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COMPLETED
NCT02291861
PHASE3

Addressing Involuntary Movements in Tardive Dyskinesia

Sponsor: Auspex Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

298

Start Date

2014-10-31

Completion Date

2016-08-19

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Placebo

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

Locations (106)

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 177

Imperial, California, United States

Teva Investigational Site 160

Irvine, California, United States

Teva Investigational Site 106

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 170

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 113

Chicago, Illinois, United States

Teva Investigational Site 164

Kansas City, Kansas, United States

Teva Investigational Site 154

Baltimore, Maryland, United States

Teva Investigational Site 101

Glen Burnie, Maryland, United States

Teva Investigational Site 135

Boston, Massachusetts, 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 172

Commack, New York, United States

Teva Investigational Site 148

New York, New York, United States

Teva Investigational Site 138

Asheville, North Carolina, United States

Teva Investigational Site 146

Raleigh, North Carolina, 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 168

Burlington, Vermont, United States

Teva Investigational Site 171

Charlottesville, Virginia, 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 558

Hradec Králové, Czechia

Teva Investigational Site 535

Litoměřice, Czechia

Teva Investigational Site 557

Pilsen, Czechia

Teva Investigational Site 533

Prague, Czechia

Teva Investigational Site 532

Prague, Czechia

Teva Investigational Site 530

Prague, Czechia

Teva Investigational Site 531

Prague, Czechia

Teva Investigational Site 534

Prague, Czechia

Teva Investigational Site 502

Gera, Germany

Teva Investigational Site 503

Haag in Oberbayern, Germany

Teva Investigational Site 504

Mainz, Germany

Teva Investigational Site 507

Prien am Chiemsee, Germany

Teva Investigational Site 544

Taufkirchen, Germany

Teva Investigational Site 501

Wolfach, Germany

Teva Investigational Site 540

Balassagyarmat, Hungary

Teva Investigational Site 538

Budapest, Hungary

Teva Investigational Site 541

Budapest, Hungary

Teva Investigational Site 537

Budapest, Hungary

Teva Investigational Site 542

Budapest, Hungary

Teva Investigational Site 539

Doba, Hungary

Teva Investigational Site 546

Győr, Hungary

Teva Investigational Site 545

Kalocsa, Hungary

Teva Investigational Site 547

Szeged, 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 515

Lublin, Poland

Teva Investigational Site 524

Lublin, Poland

Teva Investigational Site 549

Olsztyn, Poland

Teva Investigational Site 521

Pruszków, Poland

Teva Investigational Site 518

Sosnowiec, Poland

Teva Investigational Site 522

Torun, Poland

Teva Investigational Site 550

Warsaw, Poland

Teva Investigational Site 555

Warsaw, Poland

And 6 more locations on ClinicalTrials.gov