NCT00555347

Use of Armodafinil for Fatigue in Sarcoidosis

Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

Detailed description

The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment. Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life. They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.

Conditions

• Sarcoidosis
• Fatigue
• Sleepiness

Interventions

Type	Name	Description
DRUG	Armodafinil	Dosage 150-250 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-08-01
• Completion: 2011-08-01
• First posted: 2007-11-08
• Last updated: 2015-05-27

Locations

1 site across 1 country: United States