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
  Purpose

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


Condition Intervention Phase
Sarcoidosis
Fatigue
Sleepiness
Drug: Armodafinil
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: October 2007
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Armodafinil
Drug: Armodafinil
Dosage 150-250 mg
Other Name: Nuvigil
Placebo Comparator: B Drug: Placebo
Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555347

Locations
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Robert P Baughman, Prof Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00555347     History of Changes
Other Study ID Numbers: IRB 07011901
Study First Received: November 7, 2007
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
Sarcoidosis
Fatigue

Additional relevant MeSH terms:
Fatigue
Sarcoidosis
Signs and Symptoms
Lymphoproliferative Disorders
Lymphatic Diseases
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014