Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Scleroderma, Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT02166229

Run by

Yale University

People needed

0

Starts

2014-06-01

Expected to finish

2014-08-01

Last updated by the study team

2016-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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