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No subjects were enrolled.
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To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital ulcers, and joint contractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Divalproex sodium | Experimental | Divalproex sodium will be initiated at 125 mg twice daily and increased monthly to a maximum dose of 500 mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex sodium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of new digital ulcers | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified Rodnan skin score | 12 months | |
| Change in digital goniometry measurements | Goniometry measures range of motion of joints and, in this study, will include measurements of the metacarpophalangeal, proximal interphalangeal, distal interphalangeal and wrist joints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett King, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| 12 months |
| Change in hydraulic pinch and hand-grip strength measurements | 12 months |
| Change in digital circumference | 12 months |
| Change in maximum oral aperture | 12 months |
| Change in estimated affected total body surface area | 12 months |
| Scleroderma Health Assessment Questionnaire (SHAQ) | 12 months |
| Number of new lesions of calcinosis cutis | 12 months |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |