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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00294671 |
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Date of registration:
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21/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Diflunisal on Familial Amyloidosis
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Scientific title:
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The Effect of Diflunisal on Familial Amyloidosis |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00294671 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Italy
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Japan
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Portugal
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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John L. Berk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 to 75 years
- Biopsy proven amyloidosis
- Genotyping of variant transthyretin
- Signs of peripheral or autonomic neuropathy
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Familial Amyloid Polyneuropathy
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Familial Amyloidosis
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Intervention(s)
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Drug: diflunisal
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Other: placebo
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Primary Outcome(s)
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Neurologic Impairment Score + 7 (NIS+7)
[Time Frame: Baseline, 1 and 2 years]
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Secondary Outcome(s)
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Modified Body Mass Index (mBMI);
[Time Frame: Baseline, 1 and 2 years]
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Quality of Life Questionnaire: SF-36 Mental Component Score
[Time Frame: Baseline, 1 and 2 years]
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Kumamoto Neurologic Scale;
[Time Frame: Baseline, 1 and 2 years]
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Quality of Life Questionnaire: SF-36 Physical Component Score
[Time Frame: Baseline, 1 and 2 years]
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Secondary ID(s)
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FD R 002532
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R01NS051306
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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