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Sponsors and Collaborators: |
University of Cincinnati Cephalon |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00555347 |
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Condition | Intervention | Phase |
---|---|---|
Sarcoidosis Fatigue Sleepiness |
Drug: Armodafinil Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Use of Armodafinil (r-Modafinil) for Fatigue in Sarcoidosis |
Estimated Enrollment: | 20 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Armodafinil
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Drug: Armodafinil
Dosage 150-250 mg
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B: Placebo Comparator |
Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: | Robert P Baughman, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Robert P Baughman ) |
Study ID Numbers: | IRB 07011901 |
Study First Received: | November 7, 2007 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00555347 |
Health Authority: | United States: Food and Drug Administration |
Sarcoidosis Fatigue |
Lymphatic Diseases Signs and Symptoms Fatigue |
Sarcoidosis Lymphoproliferative Disorders Modafinil |
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |