A Phase 4 interventional study of d-methylphenidate in Sarcoidosis, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-24.
Sponsored by University of Cincinnati · Phase 4, Interventional, and Treatment
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.
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.
285 studies on the registry are indexed under Sarcoidosis; 58 are open to participants now.
This study's planned enrollment of 12 is below the median of 54 across 158 interventional studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
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Exclusion Criteria:
oral dosing for 8 weeks then cross over to placebo in random order
Also known as: Focalin
Improvement of fatigue.
Time frame: 30 weeks
Improvement of pulmonary status
Time frame: 30 weeks
Safety of treatment
Time frame: 30 weeks
The record gives a start of Jun 2006, a primary completion of Jun 2007 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmethylphenidate