Clinical Trial: Use of Focalin for Fatigue in Sarcoidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary: 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.
Sponsor: University of Cincinnati
Current Primary Outcome: Improvement of fatigue. [ Time Frame: 30 weeks ]
Original Primary Outcome: We will use the patients as their own controls (crossover)to measure fatigue.
Current Secondary Outcome:
- Improvement of pulmonary status [ Time Frame: 30 weeks ]
- Safety of treatment [ Time Frame: 30 weeks ]
Original Secondary Outcome:
Information By: University of Cincinnati
Dates:
Date Received: August 7, 2006
Date Started: June 2006
Date Completion:
Last Updated: February 23, 2011
Last Verified: February 2011
