Use of Focalin for Fatigue in Sarcoidosis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361387

Enrollment

Registered

2006-08-08

Start date

2006-06-30

Completion date

2008-01-31

Last updated

2011-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Keywords

Sarcoidosis, Sarcoid

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.

Interventions

DRUGd-methylphenidate

oral dosing for 8 weeks then cross over to placebo in random order

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Improvement of fatigue.	30 weeks

Secondary

Measure	Time frame
Improvement of pulmonary status	30 weeks
Safety of treatment	30 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026