Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

Yale University

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Scleroderma

Systemic Sclerosis

Treatments

Drug: Divalproex sodium

Study type

Interventional

Funder types

Other

Identifiers

NCT02166229

1404013775

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.