NCT02166229撤回1 期
Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of new digital ulcers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Divalproex sodium
Experimental
Divalproex sodium will be initiated at 125 mg twice daily and increased monthly to a maximum dose of 500 mg twice daily.
干预措施: Divalproex sodium (Drug)
结局指标
主要结局
Number of new digital ulcers
时间窗: 12 months
次要结局
- Change in estimated affected total body surface area(12 months)
- Change in digital goniometry measurements(12 months)
- Change in hydraulic pinch and hand-grip strength measurements(12 months)
- Change in modified Rodnan skin score(12 months)
- Change in digital circumference(12 months)
- Change in maximum oral aperture(12 months)
- Scleroderma Health Assessment Questionnaire (SHAQ)(12 months)
- Number of new lesions of calcinosis cutis(12 months)
研究者
研究点 (1)
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