At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 173 enrolled
Drug / intervention
Inotersen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)
In Brief
A Phase 3 clinical trial evaluating Inotersen and Placebo for FAP and 4 related conditions. Completed, enrolled 173 participants across 24 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFAP, Familial Amyloid Polyneuropathy, TTR, Transthyretin, Amyloidosis
CountriesArgentina, Brazil, France, Germany, Italy, New Zealand, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartMar 2013
Primary CompletionMar 2017
Study CompletionNov 2017
TodayJul 2026
First PostedNov 29, 2012
Enrollment StartMar 15, 2013
Primary CompletionMar 3, 2017
Study CompletionNov 7, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 13.6 years ago
Interventions
Inotersendrug
Placebodrug