Use of Armodafinil for Fatigue in Sarcoidosis

Phase 2

Completed

• Conditions: Sarcoidosis; Sleepiness; Fatigue
• Interventions: Drug: Placebo; Drug: Armodafinil

• Registration Number: NCT00555347
• Lead Sponsor: University of Cincinnati

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-07
• Study First Submitted QC: 2007-11-07
• Study First Posted: 2007-11-08
• Primary Completion: 2010-08
• Study Completion: 2011-08
• Status Verified: 2013-04
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Armnodafinil	Armodafinil	Armodafinil

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.	Prospective
To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.	Prospective

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States