Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

NCT02166229 | Withdrawn Phase 1

• 1 other identifier: 1404013775
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of new digital ulcers

  12 months

Secondary Outcomes (8)

• Change in modified Rodnan skin score

  12 months

• Change in digital goniometry measurements

  12 months

• Change in hydraulic pinch and hand-grip strength measurements

  12 months

• Change in digital circumference

  12 months

• Change in maximum oral aperture

  12 months

Study Arms (1)

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.

Drug: Divalproex sodium

Interventions

Divalproex sodium DRUG

Divalproex sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Brett King, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

US (1)