Back to resultsUse of Focalin for Fatigue in Sarcoidosis
Primary Purpose
Sarcoidosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
d-methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Sarcoid
Eligibility 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.
Sites / Locations
- University of Cincinnati Medical Center
Outcomes
Primary Outcome Measures
Improvement of fatigue.
Secondary Outcome Measures
Improvement of pulmonary status
Safety of treatment
Full Information
NCT ID
NCT00361387
First Posted
August 7, 2006
Last Updated
February 23, 2011
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00361387
Brief Title
Use of Focalin for Fatigue in Sarcoidosis
Official Title
Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
Sarcoidosis, Sarcoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
d-methylphenidate
Other Intervention Name(s)
Focalin
Intervention Description
oral dosing for 8 weeks then cross over to placebo in random order
Primary Outcome Measure Information:
Title
Improvement of fatigue.
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Improvement of pulmonary status
Time Frame
30 weeks
Title
Safety of treatment
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Baughman, MD
Organizational Affiliation
Unversity of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0565
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18263672
Citation
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.
Results Reference
derived
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Use of Focalin for Fatigue in Sarcoidosis
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