CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 126 enrolled
Drug / intervention
Nusinersen +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.

Search/NCT02292537
NCT02292537Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy

Biogen·interventional·Posted Nov 17, 2014·Updated Feb 17, 2021

In Brief

A Phase 3 clinical trial evaluating Nusinersen and Sham procedure for Spinal Muscular Atrophy. Completed, enrolled 126 participants across 24 sites in 10 countries.

Detailed Summary

The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA). The secondary objective is to examine the safety and tolerability of nusinersen administered intrathecally to participants with later-onset SMA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Muscular Atrophy
CountriesCanada, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 17, 2014
Enrollment StartNov 24, 2014
Primary CompletionFeb 20, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.6 years ago

Interventions

Nusinersendrug

Administered by intrathecal (IT) lumbar puncture (LP) injection

Sham procedureprocedure

Small needle prick on the lower back at the location where the IT injection is normally made