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Use of Focalin for Fatigue in Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361387
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : February 24, 2011
Information provided by:
University of Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Sarcoidosis Drug: d-methylphenidate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Sarcoidosis

Intervention Details:
  • Drug: d-methylphenidate
    oral dosing for 8 weeks then cross over to placebo in random order
    Other Name: Focalin

Primary Outcome Measures :
  1. Improvement of fatigue. [ Time Frame: 30 weeks ]

Secondary Outcome Measures :
  1. Improvement of pulmonary status [ Time Frame: 30 weeks ]
  2. Safety of treatment [ Time Frame: 30 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361387

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United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0565
Sponsors and Collaborators
University of Cincinnati
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Principal Investigator: Robert P Baughman, MD Unversity of Cincinnati
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert P. Baughman MD, University of Cincinnati Identifier: NCT00361387    
Other Study ID Numbers: 06-02-23-03
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011
Keywords provided by University of Cincinnati:
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents