Use of Focalin for Fatigue in Sarcoidosis
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Purpose
Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoidosis |
Drug: d-methylphenidate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects. |
- Improvement of fatigue. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- Improvement of pulmonary status [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- Safety of treatment [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
-
Drug: d-methylphenidate
This is to be a double blind, randomized trial with cross over of 12 patients with chronic sarcoidosis on stable systemic therapy. Patients will be screened for fatigue using a modified SNAP and Facit-F scores. Patients will be in the study for 20 weeks. Objective of study: To determine the effect of dexmethylphenidate hydrochloride, (d-MPH)(Focalin) on fatigue in Sarcoidosis. The is a common complaint in sarcoidosis, related to the chronic inflammatory nature of the disease. It may also related to therapy for the disease.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of sarcoidosis using standard criteria
- Disease for more than one year
- Complain of fatigue which has been present for more than six months.
- Over 18 years of age
Exclusion Criteria:
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- history of ventricular arrythmias
- Patients with a history of anxiety disorder, glaucoma, motor ties or a family history of Tourette's syndrome.
- Patients who are currently receiving or have received monoamine oxidase inhibitors within 14 days prior to study entry.
Contacts and Locations| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267-0565 | |
| Principal Investigator: | Robert P Baughman, MD | Unversity of Cincinnati |
More Information
No publications provided
| Responsible Party: | Robert P. Baughman MD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00361387 History of Changes |
| Other Study ID Numbers: | 06-02-23-03 |
| Study First Received: | August 7, 2006 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Cincinnati:
|
Sarcoidosis Sarcoid |
Additional relevant MeSH terms:
|
Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013