Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2007-10-31
2011-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Armnodafinil
Armodafinil
Armodafinil
Dosage 150-250 mg
Placebo
Placebo
Placebo
Interventions
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Armodafinil
Dosage 150-250 mg
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease for more than one year
* On stable, systemic therapy
* Complain of fatigue which has been present for more than six months.
* Over 18 years of age
* Provide written informed consent.
Exclusion Criteria
* Change in therapy for sarcoidosis in prior three months
* History of ventricular arrythmias
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
University of Cincinnati
OTHER
Responsible Party
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Robert P Baughman
Prof Medicine
Principal Investigators
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Robert P Baughman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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IRB 07011901
Identifier Type: -
Identifier Source: org_study_id
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