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Use of Armodafinil for Fatigue in Sarcoidosis

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00555347
First received: November 7, 2007
Last updated: April 10, 2013
Last verified: April 2013
History of Changes

November 7, 2007
April 10, 2013
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 ] [ Designated as safety issue: No ]
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ]
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 ] [ Designated as safety issue: No ]
  • To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sarcoidosis
  • Fatigue
  • Sleepiness
  • Drug: Armodafinil
    Dosage 150-250 mg
    Other Name: Nuvigil
  • Drug: Placebo
    Placebo
  • Active Comparator: A
    Armodafinil
    Intervention: Drug: Armodafinil
  • Placebo Comparator: B
    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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555347
IRB 07011901
No
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