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NCT00294671 · ClinicalTrials.gov registry record · Phase 2
The Effect of Diflunisal on Familial Amyloidosis
A Phase 2 study of Familial Amyloid Polyneuropathy and Familial Amyloidosis, sponsored by Boston University.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 8
- Study locations
NCT00294671: Completed Phase 2 study of Familial Amyloid Polyneuropathy and Familial Amyloidosis, sponsored by Boston University.
NCT00294671 is a Phase 2 study of Familial Amyloid Polyneuropathy and Familial Amyloidosis that has completed, run by Boston University. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00294671, a Phase 2 study of Familial Amyloid Polyneuropathy and Familial Amyloidosis, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 8
- Study locations
Study 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)
Primary Outcome
The primary endpoint, the difference in polyneuropathy progression between treatments, was measured by the Neuropathy Impairment Score plus 7 nerve tests (NIS+7) which ranges from 0 (no neurologic deficits) to 270 points (no detectable peripheral nerve function).
Conditions Studied
Interventions
- OTHER placebo
- DRUG diflunisal
Study Locations (8)
Other
- IRCCS Policlinico San Matteo - Pavia
- Kumamoto University - Kumamoto
- Shinshu University - Matsumoto
- Umea University Hospital - Umeå
- King's College Hospital - London
Massachusetts
- Amyloidosis Center, Boston Medical Center - Boston
Minnesota
- Mayo Clinic Rochester - Rochester
New York
- Mount Sinai School of Medicine, Department of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2006-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT00294671 record still lists
NCT00294671 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 2 conditions, with Familial Amyloid Polyneuropathy appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00294671 lists 8 locations in 4 states (Other, Massachusetts, Minnesota).
Frequently Asked Questions
What is clinical trial NCT00294671 about?
NCT00294671 is a clinical study titled "The Effect of Diflunisal on Familial Amyloidosis". 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)
What is the current status of trial NCT00294671?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2006-02. Estimated completion is 2012-12.
What conditions does trial NCT00294671 study?
This clinical trial studies the following conditions: Familial Amyloid Polyneuropathy, Familial Amyloidosis.
What interventions are being tested in trial NCT00294671?
The interventions under investigation include: placebo (OTHER), diflunisal (DRUG).
Who is sponsoring clinical trial NCT00294671?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00294671 being conducted?
This trial has 8 study locations across Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00294671's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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