Use of Armodafinil for Fatigue in Sarcoidosis
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
Cephalon
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00555347
First received: November 7, 2007
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoidosis Fatigue Sleepiness |
Drug: Armodafinil Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Armodafinil
|
Drug: Armodafinil
Dosage 150-250 mg
Other Name: Nuvigil
|
| Placebo Comparator: B |
Drug: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555347
Locations
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
Sponsors and Collaborators
University of Cincinnati
Cephalon
Investigators
| Principal Investigator: | Robert P Baughman, MD | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Robert P Baughman, Prof Medicine, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00555347 History of Changes |
| Other Study ID Numbers: | IRB 07011901 |
| Study First Received: | November 7, 2007 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Cincinnati:
|
Sarcoidosis Fatigue |
Additional relevant MeSH terms:
|
Fatigue Sarcoidosis Signs and Symptoms Lymphoproliferative Disorders Lymphatic Diseases Modafinil Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013