NCT00361387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

August 7, 2006

Last Update Submit

February 23, 2011

Conditions

Sarcoidosis

Keywords

SarcoidosisSarcoid

Outcome Measures

Primary Outcomes (1)

  • Improvement of fatigue.

    30 weeks

Secondary Outcomes (2)

  • Improvement of pulmonary status

    30 weeks

  • Safety of treatment

    30 weeks

Interventions

d-methylphenidateDRUG

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

Also known as: Focalin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0565, United States

Location

Related Publications (1)

  • Lower EE, Harman S, Baughman RP. Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. Chest. 2008 May;133(5):1189-95. doi: 10.1378/chest.07-2952. Epub 2008 Feb 8.

    PMID: 18263672DERIVED

MeSH Terms

Conditions

Sarcoidosis

Interventions

MethylphenidateDexmethylphenidate Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Robert P Baughman, MD

    Unversity of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 8, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

January 1, 2008

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

US(1)