Use of Armodafinil for Fatigue in Sarcoidosis
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoidosis; Fatigue; Sleepiness
Intervention: Armodafinil (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Robert P Baughman, MD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Carrie Thacker, Phone: 513-584-6252, Email: thackercl@uc.edu
Summary
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Clinical Details
Official title: Use of Armodafinil (r-Modafinil) for Fatigue in Sarcoidosis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Secondary outcome: To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.To determine the safety and tolerability of Armodafinil (Nuvigil) 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of sarcoidosis using standard criteria 15.
- 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:
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- History of ventricular arrythmias
Locations and Contacts
Carrie Thacker, Phone: 513-584-6252, Email: thackercl@uc.edu
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Carrie Thacker, Phone: 513-584-6252, Email: thackercl@uc.edu
Robert P Baughman, MD, Phone: 513-584-5225, Email: bob.baughman@uc.edu
Robert P Baughman, MD, Principal Investigator
Victoria Surdulescu, MD, Sub-Investigator
Elyse E Lower, MD, Sub-Investigator
Additional Information
Starting date: October 2007
Ending date: August 2008
Last updated: June 2, 2008
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