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Use of Armodafinil for Fatigue in Sarcoidosis

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT00555347
Collaborator
Cephalon (Industry)
20
Enrollment
1
Location
2
Arms
46
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Armnodafinil

Armodafinil

Drug: Armodafinil
Dosage 150-250 mg
Other Names:
  • Nuvigil

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [Prospective]

    Secondary Outcome Measures

    1. To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis. [Prospective]

    2. To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis. [Prospective]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cincinnati Cincinnati Ohio United States 45267

    Sponsors and Collaborators

    • University of Cincinnati
    • Cephalon

    Investigators

    • Principal Investigator: Robert P Baughman, MD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert P Baughman, Prof Medicine, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT00555347
    Other Study ID Numbers:
    • IRB 07011901
    First Posted:
    Nov 8, 2007
    Last Update Posted:
    May 27, 2015
    Last Verified:
    Apr 1, 2013
    Keywords provided by Robert P Baughman, Prof Medicine, University of Cincinnati
    Sarcoidosis
    Fatigue
    Additional relevant MeSH terms:
    Sarcoidosis
    Fatigue
    Sleepiness
    Modafinil

    Study Results

    No Results Posted as of May 27, 2015