Use of Armodafinil for Fatigue in Sarcoidosis
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|ClinicalTrials.gov Identifier: NCT00555347|
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis Fatigue Sleepiness||Drug: Armodafinil Drug: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2011|
Active Comparator: Armnodafinil
Dosage 150-250 mg
Other Name: Nuvigil
|Placebo Comparator: Placebo||
- To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ]
- To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis. [ Time Frame: Prospective ]
- To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis. [ Time Frame: Prospective ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555347
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Robert P Baughman, MD||University of Cincinnati|