Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma
NCT ID: NCT02166229
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2014-06-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Divalproex sodium
Divalproex sodium will be initiated at 125 mg twice daily and increased monthly to a maximum dose of 500 mg twice daily.
Divalproex sodium
Interventions
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Divalproex sodium
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Brett King, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1404013775
Identifier Type: -
Identifier Source: org_study_id
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