transthyretin amyloidosis MedDRA version: 12.1 Level: LLT Classification code 10019901 Term: Hereditary sensory neuropathy
Conditions
Interventions
Trade Name: Dolobid
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Diflunisal
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed