Effect of Nuvigil on Fatigue

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

December 31, 2013

Conditions
Menopause
Interventions
DRUG

Armodafinil

Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Teva Pharmaceuticals USA

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT01460628 - Effect of Nuvigil on Fatigue | Biotech Hunter | Biotech Hunter