Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

CK-2017357

Total daily oral dose of 250 mg (125 mg BID) of CK-2017357 for 7 days followed by total daily oral dose of 375 mg (125 mg AM and 250 mg PM) for 7 days followed by total daily oral dose of 500 mg (250 mg BID) of CK-2017357 for 7 days

DRUG

Placebo

Matching placebo tablets BID for 21 days

DRUG

Riluzole 50 MG

Trial Locations (11)

10021

Cornell Faculty, Hospital for Special Surgery, New York

27710

Duke University School of Medicine, Division of Neurology, Durham

43210

Ohio State University, Department of Neurology, Columbus

63110

Washington University, St Louis

78229

University of Texas Health Science Center, Department of Neurology, San Antonio

92037

Coordinated Clinical Research, La Jolla

92868

University of California at Irvine, ALS and Neuromuscular Center, Orange

93701

University of California at San Francisco, Fresno Campus, Central California Neurological Institute, Fresno

97213

Providence ALS Center, Portland

06053

Hospital for Special Care, New Britain

02129

Massachusetts General Hospital, Neurology Clinical Trials Unit, Charlestown

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cytokinetics

INDUSTRY

NCT01486849 - Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Biotech Hunter | Biotech Hunter