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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-methylphenidate | Drug | oral dosing for 8 weeks then cross over to placebo in random order |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of fatigue. | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of pulmonary status | 30 weeks | |
| Safety of treatment | 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Baughman, MD | Unversity of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267-0565 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18263672 | Derived | 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. |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D064699 | Dexmethylphenidate Hydrochloride |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |