AN OPEN LABEL EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF DIFLUNISAL IN TRANSTHYRETIN HEREDITARY AMYLOIDOSIS - ND
- Conditions
- transthyretin amyloidosisMedDRA version: 12.1Level: LLTClassification code 10019901Term: Hereditary sensory neuropathy
- Registration Number
- EUCTR2010-019829-34-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who have successfully completed protocol IND68092 (The Diflunisal Trial) 2. If female, patient is post-menopausal or willing to use an acceptable method of birth control throughout the study. 3. Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Chronic use of non-protocol, approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3 to 4 times/month. 2. If female, patient is pregnant or breastfeeding. 3. Any clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of safety and efficacy for diflunisal in patients with transthyretin amyloidosis;Secondary Objective: To continue to provide diflunisal to patients with ATTR who have completed the randomized, double-blind study with diflunisal versus placebo (The Diflunisal Trial).;Primary end point(s): Evaluation of neuropathy
- Secondary Outcome Measures
Name Time Method