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Completed

NCT Number: NCT00361387

Use of Focalin for Fatigue in Sarcoidosis

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0565, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

d-methylphenidate

Drug

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

Other names: Focalin

Primary outcomes

  1. Improvement of fatigue.

    Time frame: 30 weeks

Secondary outcomes

  1. Improvement of pulmonary status

    Time frame: 30 weeks

  2. Safety of treatment

    Time frame: 30 weeks

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Aug 8, 2006
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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