Use of Armodafinil for Fatigue in Sarcoidosis

NCT ID: NCT00555347

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sarcoidosis Fatigue Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Armnodafinil

Armodafinil

Group Type ACTIVE_COMPARATOR

Armodafinil

Intervention Type DRUG

Dosage 150-250 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Armodafinil

Dosage 150-250 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Nuvigil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Robert P Baughman

Prof Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert P Baughman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 07011901

Identifier Type: -

Identifier Source: org_study_id

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