Use of Armodafinil for Fatigue in Sarcoidosis
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis|
- To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
- To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: A
Dosage 150-250 mg
Other Name: Nuvigil
|Placebo Comparator: B||
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.
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Robert P Baughman, MD||University of Cincinnati|