Use of Armodafinil for Fatigue in Sarcoidosis

University of Cincinnati

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sarcoidosis; Sleepiness; Fatigue

Treatments: Drug: Placebo; Drug: Armodafinil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00555347

IRB 07011901

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Armnodafinil

Active Comparator group

Description:

Armodafinil

Treatment:

Drug: Armodafinil

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo