Status:
COMPLETED
The Effect of Diflunisal on Familial Amyloidosis
Lead Sponsor:
Boston University
Collaborating Sponsors:
Food and Drug Administration (FDA)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Familial Amyloid Polyneuropathy
Familial Amyloidosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine if diflunisal can prevent progressive lower leg nerve damage in patients with familial amyloidosis polyneuropathy. Funding Source - FDA Office of Orphan Prod...
Detailed Description
Familial amyloidosis polyneuropathy (FAP) is a rare, lethal, autosomal dominant, neurodegenerative disease characterized by misfolding of variant transthyretin tetramer (TTR) - a transport protein pro...
Eligibility Criteria
Inclusion
- Age 18 to 75 years
- Biopsy proven amyloidosis
- Genotyping of variant transthyretin
- Signs of peripheral or autonomic neuropathy
Exclusion
- Use of other non-steroidal anti-inflammatory drugs
- Other causes of sensorimotor polyneuropathy
- Anticipated survival \<2 years or liver transplantation in \<1 yr
- Liver transplantation
- Profound nerve, heart or kidney impairment
- Pregnancy or unwillingness to use contraception by women of childbearing age
- Active or recent gastrointestinal bleeding
- Non-steroidal or aspirin drug allergy/hypersensitivity
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00294671
Start Date
February 1 2006
End Date
December 1 2012
Last Update
March 17 2017
Active Locations (8)
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1
Amyloidosis Center, Boston Medical Center
Boston, Massachusetts, United States, 02118
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
3
Mount Sinai School of Medicine, Department of Medicine
New York, New York, United States, 10029-6574
4
IRCCS Policlinico San Matteo
Pavia, Italy, 27100