Use of Focalin for Fatigue in Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361387
• Other study ID #: 06-02-23-03
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2006
• Last updated: February 23, 2011
• Start date: June 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2011
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• d-methylphenidate
oral dosing for 8 weeks then cross over to placebo in random order

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of fatigue.		30 weeks	No
Secondary	Improvement of pulmonary status		30 weeks	No
Secondary	Safety of treatment		30 weeks	Yes