The Effect of Diflunisal on Familial Amyloidosis

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Familial Amyloid Polyneuropathy, Familial Amyloidosis

In brief

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 Products Development (OOPD); National Institute of Neurological Disorders and Stroke (NINDS)

Key facts

Study ID

NCT00294671

Run by

Boston University

People needed

130

Starts

2006-02-01

Expected to finish

2012-12-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 75 years
• Biopsy proven amyloidosis
• Genotyping of variant transthyretin
• Signs of peripheral or autonomic neuropathy

You may not qualify if…

• 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

Where it is running

• Amyloidosis Center, Boston Medical Center — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Mount Sinai School of Medicine, Department of Medicine — New York, New York, United States
• IRCCS Policlinico San Matteo — Pavia, Italy
• Kumamoto University — Kumamoto, Japan
• Shinshu University — Matsumoto, Japan
• Umea University Hospital — Umeå, Sweden
• King's College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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