EUCTR2006-001066-16-GBActive, not recruitingNot Applicable
A randomized, double-blind, placebo-controlled, international multi-center trial ofdiflunisal on neurologic disease progression in 200 familial amyloid subjects - The effect of diflunisal on familial amyloidosis
John L. Berk0 sites140 target enrollmentStarted: June 18, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Biopsy proven amyloid deposition
- •2. Genotyping of variant TTR
- •3. Signs of peripheral or autonomic neuropathy -- detectable by a
- •neurologist (performance status = 3)
- •4. Age = 18 and = 75 years
- •5. Negative ßHCG testing and contraception for sexually active women of child-bearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Use of non-study NSAIDs after enrollment (low dose aspirin allowed)
- •2. Other causes of sensorimotor polyneuropathy
- •a. Vitamin B12 deficiency
- •b. HIV patients on anti-retroviral drugs
- •c. Diabetes mellitus (Hgb A1C > 6.2%)
- •d. Chronic alcoholism (> 6 ounces hard liquor daily for 10 or greater years)
- •3. Co-morbidities with anticipated survival <2 years or liver transplantation in <1 yr
- •4. Liver transplantation
- •5. End-stage neuropathic disease (performance status > 3, parenteral nutrition, bedsores)
- •6. NYHA class IV (cardiac symptoms at rest & with minimal exertion)
- •7. Pregnancy or unwillingness to use contraception by women of childbearing age
- •8. Renal insufficiency (creatinine clearance < 30 ml/min)
- •9. Active or recent non-hemorrhoidal GI bleeding (within past 18 months)
- •10. Current anti-coagulation therapy, non-study NSAID or aspirin use
- •11. AST, ALT or Total Bilirubin > twice the upper limit of normal lab value
- •12. Non-steroidal or aspirin allergy/hypersensitivity
- •13. Thrombocytopenia (< 100,000 platelets/mm3)
- •14. Previous participation in this study
- •15. Inability or unwillingness of subject or legal guardian/representative to give written informed consent
Investigators
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