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Use of Focalin for Fatigue in Sarcoidosis

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ClinicalTrials.gov Identifier: NCT00361387
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
University of Cincinnati

Tracking Information
First Submitted Date  ICMJE August 7, 2006
First Posted Date  ICMJE August 8, 2006
Last Update Posted Date February 24, 2011
Study Start Date  ICMJE June 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
Improvement of fatigue. [ Time Frame: 30 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2006)
We will use the patients as their own controls (crossover)to measure fatigue.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
  • Improvement of pulmonary status [ Time Frame: 30 weeks ]
  • Safety of treatment [ Time Frame: 30 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Focalin for Fatigue in Sarcoidosis
Official Title  ICMJE Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sarcoidosis
Intervention  ICMJE Drug: d-methylphenidate
oral dosing for 8 weeks then cross over to placebo in random order
Other Name: Focalin
Study Arms  ICMJE Not Provided
Publications * Lower EE, Harman S, Baughman RP. Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. Chest. 2008 May;133(5):1189-95. doi: 10.1378/chest.07-2952. Epub 2008 Feb 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 7, 2006)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00361387
Other Study ID Numbers  ICMJE 06-02-23-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert P. Baughman MD, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert P Baughman, MD Unversity of Cincinnati
PRS Account University of Cincinnati
Verification Date February 2011

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