Use of Focalin for Fatigue in Sarcoidosis - Full Text View

Sponsored by:	University of Cincinnati
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00361387

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 IV

MedlinePlus related topics: Sarcoidosis

Drug Information available for: Methylphenidate hydrochloride Methylphenidate Dexmethylphenidate Dexmethylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Improvement of fatigue. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
Estimated Study Completion Date:	January 2008

Intervention Details:

oral dosing for 8 weeks then cross over to placebo in random order

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361387

Locations

United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0565

Sponsors and Collaborators

University of Cincinnati

Investigators

Principal Investigator:

Robert P Baughman, MD

Unversity of Cincinnati

More Information

Responsible Party:	University of Cincinnati ( Robert P. Baughman MD )
Study ID Numbers:	06-02-23-03
Study First Received:	August 7, 2006
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00361387
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Cincinnati:

Sarcoidosis
Sarcoid

Study placed in the following topic categories:

Lymphatic Diseases
Dopamine
Fatigue

Methylphenidate
Sarcoidosis
Lymphoproliferative Disorders

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009