Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

December 31, 2011

Study Completion Date

January 31, 2012

Conditions
Familial Amyotrophic Lateral Sclerosis
Interventions
DRUG

ISIS 333611

5 arms of 12 hour infusion: Arm 1 0.15 mg, Arm 2 0.5 mg, Arm 3 1.5 mg, Arm 4 3.0 mg, matching volume of placebo

Trial Locations (4)

21287

Johns Hopkins University, Baltimore

63110

Washington University School of Medicine, St Louis

77030

Methodist Neurological Institute, Houston

02129

Massachusetts General Hospital-East, Neurology Clinical Trials Unit, Charlestown

Sponsors
All Listed Sponsors
collaborator

Muscular Dystrophy Association

OTHER

collaborator

ALS Association

OTHER

lead

Ionis Pharmaceuticals, Inc.

INDUSTRY