Use of Armodafinil for Fatigue in Sarcoidosis

Fatigue Clinical Trial

Official title:

Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555347
• Other study ID #: IRB 07011901
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 7, 2007
• Last updated: May 26, 2015
• Start date: October 2007
• Est. completion date: August 2011

Study information

• Verified date: April 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Sarcoidosis
• Sleepiness

Intervention

Drug:
• Armodafinil
Dosage 150-250 mg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.		Prospective
Secondary	To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.		Prospective
Secondary	To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.		Prospective