At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 292 enrolled
Drug / intervention
nusinersendrug
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.
An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443
In Brief
A Phase 3 clinical trial evaluating nusinersen for Spinal Muscular Atrophy. Completed, enrolled 292 participants across 47 sites in 14 countries.
Detailed Summary
The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Muscular Atrophy
CountriesAustralia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartNov 2015
Primary CompletionAug 2023
TodayJul 2026
First PostedNov 2, 2015
Enrollment StartNov 4, 2015
Primary CompletionAug 21, 2023
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 10.7 years ago
Interventions
nusinersendrug
Administered by intrathecal (IT) injection