Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

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.