Use of Armodafinil for Fatigue in Sarcoidosis

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00555347

Enrollment

Registered

2007-11-08

Start date

2007-10-31

Completion date

2011-08-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Sarcoidosis, Sleepiness

Keywords

Sarcoidosis, Fatigue

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.

Interventions

DRUGArmodafinil

Dosage 150-250 mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026