Use of Focalin for Fatigue in Sarcoidosis

Phase 4

Completed

• Conditions: Sarcoidosis

• Registration Number: NCT00361387
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-08
• Primary Completion: 2007-06
• Study Completion: 2008-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement of fatigue.	30 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement of pulmonary status	30 weeks
Safety of treatment	30 weeks

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States