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Use of Armodafinil for Fatigue in Sarcoidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555347
First Posted: November 8, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cephalon
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
November 7, 2007
November 8, 2007
October 12, 2017
October 2007
August 2010   (Final data collection date for primary outcome measure)
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ]
Same as current
Complete list of historical versions of study NCT00555347 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of Armodafinil for Fatigue in Sarcoidosis
Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2011
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00555347
IRB 07011901
No
Not Provided
Not Provided
Robert P Baughman, University of Cincinnati
University of Cincinnati
Cephalon
Principal Investigator: Robert P Baughman, MD University of Cincinnati
University of Cincinnati
April 2013

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