Use of Armodafinil for Fatigue in Sarcoidosis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 7, 2007

Last Updated Date

November 19, 2008

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00555347 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Use of Armodafinil for Fatigue in Sarcoidosis

Official Title ^ICMJE

Use of Armodafinil (r-Modafinil) for Fatigue in Sarcoidosis

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.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sarcoidosis
Fatigue
Sleepiness

Intervention ^ICMJE

Drug: Armodafinil
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Armodafinil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00555347

Responsible Party

Robert P Baughman, University of Cincinnati

Study ID Numbers ^ICMJE

IRB 07011901

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

Cephalon

Investigators ^ICMJE

Principal Investigator:

Robert P Baughman, MD

University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP