At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 280 enrolled
Drug / intervention
tirasemtivdrug
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, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)
In Brief
A Phase 3 clinical trial evaluating tirasemtiv for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 280 participants across 67 sites in 11 countries.
Detailed Summary
The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis (ALS)
CountriesBelgium, Canada, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionOct 2018
TodayJul 2026
First PostedOct 18, 2016
Enrollment StartOct 17, 2016
Primary CompletionOct 26, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.7 years ago
Interventions
tirasemtivdrug
Oral