Addressing Involuntary Movements in Tardive Dyskinesia

Last updated: November 5, 2021
Sponsor: Auspex Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Tardive Dyskinesia

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT02291861
SD-809-C-23
2014-003135-19
  • Ages 18-80
  • All Genders

Study 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

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 monthsprior to screening
  • Subjects with underlying psychiatric diagnosis are stable and have no change inpsychoactive medications
  • Have a mental health provider and does not anticipate any changes to treatment regimenin 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 completestudy assessments
  • Female subjects must not be pregnant and must agree to an acceptable method ofcontraception throughout the study

Exclusion

Exclusion Criteria:

  • Currently receiving medication for the treatment of tardive dyskinesia
  • Have a neurological condition other than tardive dyskinesia that may interfere withassessing 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 ordevice within 30 days
  • Have acknowledged use of illicit drugs
  • Have a history of alcohol or substance abuse in the previous 12 months

Study Design

Total Participants: 298
Study Start date:
October 31, 2014
Estimated Completion Date:
August 19, 2016

Connect with a study center

  • Teva Investigational Site 556

    Hositivce,
    Czech Republic

    Site Not Available

  • Teva Investigational Site 559

    Havirov, 736 01
    Czechia

    Site Not Available

  • Teva Investigational Site 556

    Hostivice,
    Czechia

    Site Not Available

  • Teva Investigational Site 558

    Hradec Kralove, 503 41
    Czechia

    Site Not Available

  • Teva Investigational Site 535

    Litomerice, 412 01
    Czechia

    Site Not Available

  • Teva Investigational Site 557

    Plzen, 312 00
    Czechia

    Site Not Available

  • Teva Investigational Site 530

    Prague 6, 16000
    Czechia

    Site Not Available

  • Teva Investigational Site 531

    Prague 8, 181 02
    Czechia

    Site Not Available

  • Teva Investigational Site 533

    Praha 10, 100 00
    Czechia

    Site Not Available

  • Teva Investigational Site 532

    Praha 5, 158 00
    Czechia

    Site Not Available

  • Teva Investigational Site 534

    Praha 9, 190 00
    Czechia

    Site Not Available

  • Teva Investigational Site 502

    Gera, 07551
    Germany

    Site Not Available

  • Teva Investigational Site 503

    Haag In Oberbayern, 83527
    Germany

    Site Not Available

  • Teva Investigational Site 503

    Haag i.OB,
    Germany

    Site Not Available

  • Teva Investigational Site 505

    Koln,
    Germany

    Site Not Available

  • Teva Investigational Site 504

    Mainz, 55131
    Germany

    Site Not Available

  • Teva Investigational Site 507

    Prien am Chiemsee, 83209
    Germany

    Site Not Available

  • Teva Investigational Site 544

    Taufkirchen, 84416
    Germany

    Site Not Available

  • Teva Investigational Site 501

    Wolfach, 77709
    Germany

    Site Not Available

  • Teva Investigational Site 540

    Balassagyarmat,
    Hungary

    Site Not Available

  • Teva Investigational Site 537

    Budapest, 1204
    Hungary

    Site Not Available

  • Teva Investigational Site 538

    Budapest, 1135
    Hungary

    Site Not Available

  • Teva Investigational Site 541

    Budapest, 1148
    Hungary

    Site Not Available

  • Teva Investigational Site 542

    Budapest, H-1135
    Hungary

    Site Not Available

  • Teva Investigational Site 539

    Doba, 8482
    Hungary

    Site Not Available

  • Teva Investigational Site 546

    Gyor, 9024
    Hungary

    Site Not Available

  • Teva Investigational Site 545

    Kalocsa, 6300
    Hungary

    Site Not Available

  • Teva Investigational Site 547

    Szeged, 6725
    Hungary

    Site Not Available

  • Teva Investigational Site 514

    Belchatow, 97-400
    Poland

    Site Not Available

  • Teva Investigational Site 554

    Bialystok, 15-756
    Poland

    Site Not Available

  • Teva Investigational Site 510

    Bydgoszcz, 85-015
    Poland

    Site Not Available

  • Teva Investigational Site 519

    Bydgoszcz, 85-080
    Poland

    Site Not Available

  • Teva Investigational Site 536

    Bydgoszcz, 85-156
    Poland

    Site Not Available

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    Bydogoszcz,
    Poland

    Site Not Available

  • Teva Investigational Site 523

    Chelmno, 86-200
    Poland

    Site Not Available

  • Teva Investigational Site 523

    Chełmno,
    Poland

    Site Not Available

  • Teva Investigational Site 517

    Choroszcz, 16-070
    Poland

    Site Not Available

  • Teva Investigational Site 513

    Gdansk, 80-952
    Poland

    Site Not Available

  • Teva Investigational Site 512

    Katowice, 40-097
    Poland

    Site Not Available

  • Teva Investigational Site 552

    Katowice, 40-123
    Poland

    Site Not Available

  • Teva Investigational Site 509

    Krakow, 31-505
    Poland

    Site Not Available

  • Teva Investigational Site 520

    Krakow, 30-349
    Poland

    Site Not Available

  • Teva Investigational Site 508

    Lodz, 90-130
    Poland

    Site Not Available

  • Teva Investigational Site 511

    Lublin, 20-064
    Poland

    Site Not Available

  • Teva Investigational Site 515

    Lublin, 20-090
    Poland

    Site Not Available

  • Teva Investigational Site 524

    Lublin, 20-831
    Poland

    Site Not Available

  • Teva Investigational Site 549

    Olsztyn, 10-443
    Poland

    Site Not Available

  • Teva Investigational Site 521

    Pruszkow, 05-802
    Poland

    Site Not Available

  • Teva Investigational Site 518

    Sosnowiec, 41-200
    Poland

    Site Not Available

  • Teva Investigational Site 522

    Torun, 87-100
    Poland

    Site Not Available

  • Teva Investigational Site 550

    Warszawa, 00-465
    Poland

    Site Not Available

  • Teva Investigational Site 555

    Warszawa, 00-669
    Poland

    Site Not Available

  • Teva Investigational Site 516

    Wroclaw, 50-227
    Poland

    Site Not Available

  • Teva Investigational Site 529

    Bratislava, 826 06
    Slovakia

    Site Not Available

  • Teva Investigational Site 525

    Hronovce, 935 61
    Slovakia

    Site Not Available

  • Teva Investigational Site 527

    Kosice, 04017
    Slovakia

    Site Not Available

  • Teva Investigational Site 527

    Kosice 4 - Barca,
    Slovakia

    Site Not Available

  • Teva Investigational Site 528

    Rimavska Sobota, 979 12
    Slovakia

    Site Not Available

  • Teva Investigational Site 526

    Roznava, 04801
    Slovakia

    Site Not Available

  • Teva Investigational Site 145

    Tuscaloosa, Alabama 35404
    United States

    Site Not Available

  • Teva Investigational Site 107

    Anaheim, California 92804
    United States

    Site Not Available

  • Teva Investigational Site 108

    Anaheim, California 92805
    United States

    Site Not Available

  • Teva Investigational Site 123

    Glendale, California 91206
    United States

    Site Not Available

  • Teva Investigational Site 177

    Imperial, California 92251
    United States

    Site Not Available

  • Teva Investigational Site 106

    Irvine, California 92697
    United States

    Site Not Available

  • Teva Investigational Site 160

    Irvine, California 92614
    United States

    Site Not Available

  • Teva Investigational Site 176

    Loma Linda, California 92354
    United States

    Site Not Available

  • Teva Investigational Site 121

    Los Angeles, California 90033
    United States

    Site Not Available

  • Teva Investigational Site 147

    Los Angeles, California 90095-1769
    United States

    Site Not Available

  • Teva Investigational Site 174

    Norwalk, California 90650
    United States

    Site Not Available

  • Teva Investigational Site 170

    Oceanside, California 92056
    United States

    Site Not Available

  • Teva Investigational Site 102

    Orange, California 92868
    United States

    Site Not Available

  • Teva Investigational Site 104

    San Bernadino, California
    United States

    Site Not Available

  • Teva Investigational Site 104

    San Bernardino, California 92408
    United States

    Site Not Available

  • Teva Investigational Site 110

    San Diego, California 92108
    United States

    Site Not Available

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    San Francisco, California
    United States

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  • Teva Investigational Site 169

    San Rafael, California 94901
    United States

    Site Not Available

  • Teva Investigational Site 129

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Teva Investigational Site 139

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Teva Investigational Site 139

    NewHaven, Connecticut
    United States

    Site Not Available

  • Teva Investigational Site 156

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Teva Investigational Site 157

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Teva Investigational Site 117

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Teva Investigational Site 150

    Lake City, Florida 32025
    United States

    Site Not Available

  • Teva Investigational Site 153

    Miami, Florida 33135
    United States

    Site Not Available

  • Teva Investigational Site 162

    Miami, Florida 33165
    United States

    Site Not Available

  • Teva Investigational Site 112

    Orlando, Florida 32803
    United States

    Site Not Available

  • Teva Investigational Site 144

    Port Charlotte, Florida 33980
    United States

    Site Not Available

  • Teva Investigational Site 155

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Teva Investigational Site 165

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Teva Investigational Site 113

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Teva Investigational Site 131

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Teva Investigational Site 164

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Teva Investigational Site 154

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Teva Investigational Site 101

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • Teva Investigational Site 135

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Teva Investigational Site 118

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Teva Investigational Site 142

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Teva Investigational Site 161

    Saint Louis, Missouri 63109
    United States

    Site Not Available

  • Teva Investigational Site 175

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Teva Investigational Site 161

    St. Louis, Missouri
    United States

    Site Not Available

  • Teva Investigational Site 178

    Lincoln, Nebraska 68526-9467
    United States

    Site Not Available

  • Teva Investigational Site 128

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Teva Investigational Site 172

    Commack, New York 11725
    United States

    Site Not Available

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    Long Island, New York
    United States

    Site Not Available

  • Teva Investigational Site 148

    New York, New York 10032
    United States

    Site Not Available

  • Teva Investigational Site 138

    Asheville, North Carolina 28805
    United States

    Site Not Available

  • Teva Investigational Site 146

    Raleigh, North Carolina
    United States

    Site Not Available

  • Teva Investigational Site 133

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Teva Investigational Site 149

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Teva Investigational Site 151

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Teva Investigational Site 115

    Salt Lake City, Utah 84105
    United States

    Site Not Available

  • Teva Investigational Site 141

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Teva Investigational Site 168

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Teva Investigational Site 171

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Teva Investigational Site 167

    Richland, Washington 99352
    United States

    Site Not Available

  • Teva Investigational Site 166

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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