Modafinil for Treatment of Fatigue in ALS Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Fatigue
Interventions
DRUG

Modafinil

Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.

DRUG

Placebo

Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.

Trial Locations (1)

10032

New York State Psychiatric Institute-Columbia University, New York

All Listed Sponsors
lead

New York State Psychiatric Institute

OTHER

NCT00614926 - Modafinil for Treatment of Fatigue in ALS Patients | Biotech Hunter | Biotech Hunter