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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02166229
Other study ID # 1404013775
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received June 10, 2014
Last updated August 10, 2016
Start date June 2014
Est. completion date August 2014

Study information

Verified date August 2016
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Divalproex sodium


Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of new digital ulcers 12 months No
Secondary Change in modified Rodnan skin score 12 months No
Secondary Change in digital goniometry measurements Goniometry measures range of motion of joints and, in this study, will include measurements of the metacarpophalangeal, proximal interphalangeal, distal interphalangeal and wrist joints. 12 months No
Secondary Change in hydraulic pinch and hand-grip strength measurements 12 months No
Secondary Change in digital circumference 12 months No
Secondary Change in maximum oral aperture 12 months No
Secondary Change in estimated affected total body surface area 12 months No
Secondary Scleroderma Health Assessment Questionnaire (SHAQ) 12 months No
Secondary Number of new lesions of calcinosis cutis 12 months
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