Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

Systemic Sclerosis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02166229
• Other study ID #: 1404013775
• Status: Withdrawn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• Status: Withdrawn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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

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