At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 130 enrolled
Drug / intervention
diflunisal +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Diflunisal on Familial Amyloidosis
In Brief
A Phase 3 clinical trial evaluating diflunisal and placebo for Familial Amyloid Polyneuropathy and Familial Amyloidosis. Completed, enrolled 130 participants across 8 sites in 5 countries.
Detailed 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 Products Development (OOPD); National Institute of Neurological Disorders and Stroke (NINDS)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, Japan, Sweden, United Kingdom, United States
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedFeb 2006
Primary CompletionDec 2012
TodayJul 2026
First PostedFeb 22, 2006
Enrollment StartFeb 1, 2006
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.4 years ago
Interventions
diflunisaldrug
given twice daily for 24 months
placeboother
an inactive substance given twice daily for 24 months