Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
NocturiaDaytime Sleepiness
Interventions
DRUG

Armodafinil

Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.

DRUG

Placebo

Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT02151253 - Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia | Biotech Hunter | Biotech Hunter