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The Effect of Diflunisal on Familial Amyloidosis

NCT00294671 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2017-03-17

Study results available
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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)

Conditions

  • Familial Amyloid Polyneuropathy
  • Familial Amyloidosis

Interventions

DRUG

diflunisal

given twice daily for 24 months

OTHER

placebo

an inactive substance given twice daily for 24 months

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • John L. Berk, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Italy
  • Japan
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294671 on ClinicalTrials.gov