At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 168 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 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
In Brief
A Phase 3 clinical trial evaluating Inotersen and Eplontersen for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy. Completed, enrolled 168 participants across 45 sites in 16 countries.
Detailed Summary
The main objective of this study was to evaluate the efficacy of eplontersen as compared with the historical control of the placebo cohort in the NEURO-TTR trial (NCT01737398/2012-001831-30), in subjects with hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN). For more information, please visit http://www.neuro-ttransform.com/.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Canada, Cyprus, France, Germany, Greece, Italy, New Zealand, Portugal, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartDec 2019
Primary CompletionApr 2023
Study CompletionJul 2023
TodayJul 2026
First PostedOct 23, 2019
Enrollment StartDec 11, 2019
Primary CompletionApr 11, 2023
Study CompletionJul 12, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.7 years ago
Interventions
Inotersendrug
Inotersen by subcutaneous injection
Eplontersendrug
Eplontersen by subcutaneous injection