Use of Focalin for Fatigue in Sarcoidosis

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00361387
First received: August 7, 2006
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Sarcoidosis
Drug: d-methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Improvement of fatigue. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of pulmonary status [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
  • Safety of treatment [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: June 2006
Study Completion Date: January 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: d-methylphenidate
    oral dosing for 8 weeks then cross over to placebo in random order
    Other Name: Focalin
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361387

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0565
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Robert P Baughman, MD Unversity of Cincinnati
  More Information

No publications provided

Responsible Party: Robert P. Baughman MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00361387     History of Changes
Other Study ID Numbers: 06-02-23-03
Study First Received: August 7, 2006
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
Sarcoidosis
Sarcoid

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014