Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

September 30, 2009

Conditions
Pseudobulbar Affect (PBA)
Interventions
DRUG

dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg

Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period

DRUG

dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg

Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 30 mg/ Q 10 mg taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period

DRUG

Placebo

Placebo capsules (identical in appearance to AVP-923 capsules being studied in this trial), taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period

Trial Locations (62)

10029

Mount Sinai Medical Center, New York

10032

Neurological Institute - Columbia Presbyterian Center, New York

12205

Upstate Clinical Research, Albany

14203

Jacobs Neurological Institute, Buffalo

19107

Drexel University - Department of Neurology, Philadelphia

The ALS Center - Penn Neurological Institute - The University of Pennsylvania, Philadelphia

21287

The John Hopkins Universitiy, Baltimore

26506

West Virginia University, Morgantown

27710

Duke Universitiy Medical Center, Durham

28207

Carolinas Medical Center, Charlotte

30033

Neurology Specialists of Decatur of Decatur, Decatur

30322

The ALS Center at Emory University, Atlanta

32224

Mayo Clinic, Jacksonville

33136

University of Miami, Miami

33334

Neuroscience Center, Fort Lauderdale

33701

Suncoast Neuroscience Associates, St. Petersburg

37232

Vanderbilt University, Nashville

40536

University of Kentucky Health Care - Dept. of Neurology, Lexington

43210

Ohio State Universitiy, Columbus

44195

Department of Neurology - The Cleveland Clinic Foundation, Cleveland

48109

University of Michigan, Ann Arbor

48202

Henry Ford Hospital, Detroit

53715

Dean Foundation, Madison

59405

Advanced Neurology Specialists, Great Falls

60062

Consultants in Neurology, Northbrook

60611

Northwestern University, Chicago

63110

St.Louis University - Neuromuscular Clinic, St Louis

68506

Neurology Associates, Lincoln

77030

The Methodist Hospital - Baylor College of Medicine, Houston

78229

University of Texas Health Science Center, San Antonio

79430

Department of Neuropsychiatry - Texas Tech University, Lubbock

80045

University of Colorado at Denver & Health Science Center, Aurora

85013

St. Joseph's Hospital and Medical Center, Phoenix

85258

Neuromuscular Research Center, Scottsdale

89102

Universitiy of Nevada, Las Vegas

90095

UCLA School of Medicine, Los Angeles

92103

Center for Neurologic Study, La Jolla

92804

South Coast Clinical Trials, Anaheim

92868

UCI Medical Center, Irvine

94115

The Forbes Norris MDA/ALS Research Center - California Pacific Medical Center, San Francisco

94117

The ALS Center at UCSF, San Francisco

97239

Oregon Health Science University, Portland

02129

Massachusets General Hospital, Boston

01199

Baystate Medical Center, Springfield

05405

Universitiy of Vermont, Burlington

1117ABD

FACENE, Buenos Aires

C1055AAD

IADIN, Buenos Aires

C1181ACH

Hospital Italiano, Buenos Aires

C1192AAW

INEBA, Buenos Aires

C1221ADC

Hospital Ramos Mejia, Buenos Aires

C1280AEB

Hospital Britanico, Buenos Aires

C1416DRJ

Policlinico Bancario, Buenos Aires

C1428AQK

FLENI, Buenos Aires

X5000HGX

Hospital Militar Regional de Cordoba, Córdoba

M5501AAP

Instituto Medico Rodriguez Alfici, Godoy Cruz

2002KQJ

Instituto de Neurociencias Rosario, Rosario

30.150-221

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

80.060.900

Hospital de Clínicas-UFPR, Curitiba

52.010-040

Hospital da Restauração, Recife

21941-913

Hospital Universitário Clementino Fraga Filho, Rio de Janeiro

90.560.030

Hospital Moinhos de Vento, Porto Alegre

05.403-000

Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Avanir Pharmaceuticals

INDUSTRY