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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
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE November 7, 2007
First Posted Date  ICMJE November 8, 2007
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Armodafinil for Fatigue in Sarcoidosis
Official Title  ICMJE Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
Brief Summary To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoidosis
  • Fatigue
  • Sleepiness
Intervention  ICMJE
  • Drug: Armodafinil
    Dosage 150-250 mg
    Other Name: Nuvigil
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Armnodafinil
    Armodafinil
    Intervention: Drug: Armodafinil
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2007)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555347
Other Study ID Numbers  ICMJE IRB 07011901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert P Baughman, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Cephalon
Investigators  ICMJE
Principal Investigator: Robert P Baughman, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP