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Use of Armodafinil for Fatigue in Sarcoidosis

Primary Purpose

Sarcoidosis, Fatigue, Sleepiness

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Armodafinil
Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Armnodafinil

Placebo

Arm Description

Armodafinil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2007
Last Updated
May 26, 2015
Sponsor
University of Cincinnati
Collaborators
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00555347
Brief Title
Use of Armodafinil for Fatigue in Sarcoidosis
Official Title
Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Fatigue, Sleepiness
Keywords
Sarcoidosis, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Armnodafinil
Arm Type
Active Comparator
Arm Description
Armodafinil
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Other Intervention Name(s)
Nuvigil
Intervention Description
Dosage 150-250 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.
Time Frame
Prospective
Title
To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Baughman, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

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Use of Armodafinil for Fatigue in Sarcoidosis

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