Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

PHASE3TerminatedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

May 25, 2018

Primary Completion Date

May 15, 2020

Study Completion Date

May 15, 2020

Conditions
Tourette Syndrome
Interventions
DRUG

TEV-50717

6, 9, and 12 mg oral tablets

DRUG

Placebo

Placebo comparator

Trial Locations (76)

1021

Teva Investigational Site 060-0901, Budapest

1900

Teva Investigational Site 060-1403, La Plata

2170

Teva Investigational Site 060-1802, Liverpool

2730

Teva Investigational Site 046-0302, Herlev

4080

Teva Investigational Site 060-2007, Kiev

4209

Teva Investigational Site 060-2005, Kyiv

5000

Teva Investigational Site 046-0301, Odense

5500

Teva Investigational Site 060-1404, Mendoza

6351

Teva Investigational Site 060-1902, Seoul

6725

Teva Investigational Site 060-0902, Szeged

10029

Teva Investigational Site 046-0124, New York

10036

Teva Investigational Site 060-0154, New York

11000

Teva Investigational Site 046-1702, Belgrade

Teva Investigational Site 046-1703, Belgrade

14618

Teva Investigational Site 046-0102, Rochester

21000

Teva Investigational Site 046-1701, Novi Sad

21005

Teva Investigational Site 060-2006, Vinnytsia

23805

Teva Investigational Site 046-0118, Petersburg

28009

Teva Investigational Site 046-0605, Madrid

28922

Teva Investigational Site 046-0602, Madrid

29620

Teva Investigational Site 046-0603, Málaga

30331

Teva Investigational Site 046-0116, Atlanta

31503

Teva Investigational Site 060-1105, Krakow

32608

Teva Investigational Site 060-0160, Gainesville

32803

Teva Investigational Site 046-0115, Orlando

32819

Teva Investigational Site 060-0153, Orlando

33701

Teva Investigational Site 046-0114, St. Petersburg

36303

Teva Investigational Site 046-0104, Dothan

37000

Teva Investigational Site 060-1603, León

41013

Teva Investigational Site 046-0601, Seville

49101

Teva Investigational Site 060-2003, Dnipropetrovsk

60563

Teva Investigational Site 046-0133, Naperville

60612

Teva Investigational Site 060-0155, Chicago

60634

Teva Investigational Site 060-0164, Chicago

61068

Teva Investigational Site 060-2001, Kharkiv

61153

Teva Investigational Site 060-2002, Kharkiv

63044

Teva Investigational Site 060-0170, Bridgeton

63304

Teva Investigational Site 046-0110, Saint Charles

64460

Teva Investigational Site 060-1602, Monterrey

64610

Teva Investigational Site 060-1604, Monterrey

72758

Teva Investigational Site 046-0107, Rogers

73116

Teva Investigational Site 046-0106, Oklahoma City

75243

Teva Investigational Site 046-0113, Dallas

76104

Teva Investigational Site 060-0163, Fort Worth

77030

Teva Investigational Site 046-0108, Houston

78249

Teva Investigational Site 046-0120, San Antonio

80020

Teva Investigational Site 060-1601, Culiacán

80131

Teva Investigational Site 060-1003, Naples

84058

Teva Investigational Site 046-0105, Orem

92108

Teva Investigational Site 046-0111, San Diego

92805

Teva Investigational Site 046-0126, Anaheim

95123

Teva Investigational Site 060-1001, Catania

95815

Teva Investigational Site 046-0101, Sacramento

394024

Teva Investigational Site 046-0703, Voronezh

634050

Teva Investigational Site 046-0704, Tomsk

660003

Teva Investigational Site 060-1504, Pereira

32561-4458

Teva Investigational Site 060-0166, Gulf Breeze

33136-2107

Teva Investigational Site 060-0161, Miami

02114

Teva Investigational Site 046-0128, Boston

68526-9467

Teva Investigational Site 046-0134, Lincoln

08043

Teva Investigational Site 046-0109, Voorhees Township

29414-5834

Teva Investigational Site 060-0169, Charleston

37232-2551

Teva Investigational Site 060-0156, Nashville

98201-4077

Teva Investigational Site 060-0162, Everett

C1023AAB

Teva Investigational Site 060-1407, Buenos Aires

C1425AHQ

Teva Investigational Site 060-1402, Buenos Aires

L1Z0M1

Teva Investigational Site 046-0201, Ajax

K2G 1W2

Teva Investigational Site 046-0202, Ottawa

051050

Teva Investigational Site 060-1503, Bello

09121

Teva Investigational Site 060-1005, Cagliari

80-542

Teva Investigational Site 060-1104, Gdansk

40-123

Teva Investigational Site 060-1101, Katowice

60-693

Teva Investigational Site 060-1102, Poznan

02-793

Teva Investigational Site 060-1103, Warsaw

110-744

Teva Investigational Site 060-1901, Seoul

138-736

Teva Investigational Site 060-1903, Seoul

Sponsors
All Listed Sponsors
collaborator

Nuvelution TS Pharma, Inc.

INDUSTRY

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY