Use of Armodafinil for Fatigue in Sarcoidosis

May 26, 2015 updated by: Robert P Baughman, University of Cincinnati

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Active Comparator: Armnodafinil
Armodafinil
Drug: Armodafinil
Dosage 150-250 mg
Other Names:
  • Nuvigil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Cephalon

Investigators

  • Principal Investigator: Robert P Baughman, MD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimate)

November 8, 2007

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 07011901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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