Skip to main content
OpenTrials
Completed

NCT Number: NCT00555347

Use of Armodafinil for Fatigue in Sarcoidosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoidosis Fatigue Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Armodafinil

Drug

Dosage 150-250 mg

Other names: Nuvigil

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: Prospective

Secondary outcomes

  1. To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.

    Time frame: Prospective

  2. To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.

    Time frame: Prospective

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Cephalon

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Nov 8, 2007
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.