Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

PHASE3TerminatedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Traumatic Brain Injury
Interventions
DRUG

Armodafinil

Armodafinil 50 mg/day

DRUG

Armodafinil

Armodafinil 150 mg/day

DRUG

Armodafinil

Armodafinil 250 mg/day

OTHER

Placebo

Placebo

Trial Locations (73)

10010

Teva Investigational Site 72, New York

10019

Teva Investigational Site 63, New York

10117

Teva Investigational Site 405, Berlin

14224

Teva Investigational Site 36, West Seneca

15025

Teva Investigational Site 13, Jefferson Hills

18411

Teva Investigational Site 64, Clarks Summit

23249

Teva Investigational Site 24, Richmond

27157

Teva Investigational Site 45, Winston-Salem

27710

Teva Investigational Site 11, Durham

28036

Teva Investigational Site 701, Madrid

29201

Teva Investigational Site 65, Columbia

30024

Teva Investigational Site 15, Suwanee

30281

Teva Investigational Site 29, Stockbridge

30321

Teva Investigational Site 26, Atlanta

30342

Teva Investigational Site 12, Atlanta

Teva Investigational Site 14, Atlanta

30501

Teva Investigational Site 68, Gainesville

31201

Teva Investigational Site 67, Macon

32806

Teva Investigational Site 1, Orlando

33009

Teva Investigational Site 52, Hallandale

33026

Teva Investigational Site 18, Pembroke Pines

33173

Teva Investigational Site 47, Miami

33607

Teva Investigational Site 17, Tampa

33707

Teva Investigational Site 38, St. Petersburg

34609

Teva Investigational Site 10, Spring Hill

35213

Teva Investigational Site 58, Birmingham

38139

Teva Investigational Site 61, Germantown

39402

Teva Investigational Site 7, Hattiesburg

40217

Teva Investigational Site 48, Louisville

43623

Teva Investigational Site 30, Toledo

44130

Teva Investigational Site 57, Middleburg Heights

45227

Teva Investigational Site 31, Cincinnati

45246

Teva Investigational Site 34, Cincinnati

46122

Teva Investigational Site 28, Danville

46250

Teva Investigational Site 2, Indianapolis

46260

Teva Investigational Site 39, Indianapolis

46805

Teva Investigational Site 19, Fort Wayne

48604

Teva Investigational Site 22, Saginaw

52242

Teva Investigational Site 41, Iowa City

53227

Teva Investigational Site 50, West Allis

56126

Teva Investigational Site 501, Pisa

63143

Teva Investigational Site 42, St Louis

66201

Teva Investigational Site 9, Shawnee Mission

68510

Teva Investigational Site 56, Lincoln

71913

Teva Investigational Site 16, Hot Springs

72205

Teva Investigational Site 5, Little Rock

73112

Teva Investigational Site 3, Oklahoma City

75235

Teva Investigational Site 25, Dallas

77030

Teva Investigational Site 8, Houston

77063

Teva Investigational Site 20, Houston

77339

Teva Investigational Site 73, Kingwood

78229

Teva Investigational Site 23, San Antonio

78756

Teva Investigational Site 60, Austin

80331

Teva Investigational Site 404, München

84047

Teva Investigational Site 35, Midvale

Teva Investigational Site 66, Midvale

85712

Teva Investigational Site 62, Tucson

85723

Teva Investigational Site 40, Tucson

90404

Teva Investigational Site 53, Santa Monica

90623

Teva Investigational Site 49, La Palma

Teva Investigational Site 51, La Palma

92103

Teva Investigational Site 55, San Diego

92161

Teva Investigational Site 33, San Diego

92708

Teva Investigational Site 44, Fountain Valley

95655

Teva Investigational Site 71, Mather

06492

Teva Investigational Site 69, Wallingford

60675-6714

Teva Investigational Site 46, Chicago

Teva Investigational Site 54, Chicago

Teva Investigational Site 59, Chicago

20815-6901

Teva Investigational Site 32, Chevy Chase

02478

Teva Investigational Site 37, Belmont

02135

Teva Investigational Site 70, Brighton

08003

Teva Investigational Site 704, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon, Inc.

INDUSTRY

NCT00893789 - Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury | Biotech Hunter | Biotech Hunter