Clinical trial NCT02166229: Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Scleroderma
Systemic Sclerosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of new digital ulcers
timeFrame: 12 months
Secondary outcomes:
measure: Change in modified Rodnan skin score
timeFrame: 12 months
measure: Change in digital goniometry measurements
timeFrame: 12 months
measure: Change in hydraulic pinch and hand-grip strength measurements
timeFrame: 12 months
measure: Change in digital circumference
timeFrame: 12 months
measure: Change in maximum oral aperture
timeFrame: 12 months
measure: Change in estimated affected total body surface area
timeFrame: 12 months
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: 12 months
measure: Number of new lesions of calcinosis cutis
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Brett King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: