Use of Armodafinil for Fatigue in Sarcoidosis - Full Text View

Sponsor:	University of Cincinnati
Collaborator:	Cephalon
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00555347

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Use of Armodafinil (r-Modafinil) for Fatigue in Sarcoidosis

Resource links provided by NLM:

MedlinePlus related topics: Sarcoidosis

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Armodafinil	Drug: Armodafinil Dosage 150-250 mg
B: Placebo Comparator	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

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:	University of Cincinnati ( Robert P Baughman )
Study ID Numbers:	IRB 07011901
Study First Received:	November 7, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00555347 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Cincinnati:

Sarcoidosis
Fatigue

Additional relevant MeSH terms:

Fatigue
Physiological Effects of Drugs
Central Nervous System Stimulants
Sarcoidosis
Neuroprotective Agents
Protective Agents
Modafinil

Pharmacologic Actions
Signs and Symptoms
Lymphatic Diseases
Therapeutic Uses
Lymphoproliferative Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009