Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

• Status: Withdrawn
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• 18 years of age or older

• Diagnosis of scleroderma as defined by the American College of Rheumatology (ACR)

• Presence of at least one digital manifestation occurring within the past 6 months, i.e. digital swelling/edema, digital ulcer, calcinosis cutis, restricted digital range of motion.

• Females of childbearing potential must take an oral contraceptive pill or use an equivalent birth control method during the study.

Exclusion Criteria:

• Age <18 years old

• Ongoing use of high dose steroids (>10 mg/day) or unstable steroid dose in past 4 weeks.

• An investigational drug or disease-modifying agent has been started within the past 6 months, including but not limited to systemic corticosteroids, methotrexate, cyclosporine, azathioprine, cyclophosphamide, bosentan, mycophenolate mofetil, thalidomide, colchicine.

• Patient taking a medication with a significant drug-drug interaction with divalproex sodium, e.g. clomipramine and lamotrigine.

• Patient has another connective tissue disease or other condition that could affect rest pain and hand function, e.g. systemic lupus erythematosus, rheumatoid arthritis, or osteoarthritis.

• Patient has uncontrolled diabetes, chronic kidney disease, chronic hepatitis.

• Any of the following laboratory abnormalities at baseline: anemia (Hb < 8.5 gm/dL), thrombocytopenia with platelets <100,000, INR > 1.3 or known bleeding disorder, estimated GFR < 60 mL/min/1.73m2 or serum creatinine > 2.0 mg/dL, hyperbilirubinemia or elevation of AST or ALT

• Pregnancy or breast-feeding.

• History of severe depression (i.e. depression requiring medical treatment by a psychiatrist), suicidal ideation, epilepsy, bipolar disorder, or schizophrenia.