At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
EPI-589drug
Likely dose
EPI-589 250 mgfrom 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 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral Sclerosis
In Brief
A Phase 2 clinical trial evaluating EPI-589 for Amyotrophic Lateral Sclerosis. Completed, enrolled 19 participants across 3 sites.
Detailed Summary
This is an open label study with 30-day run in phase to establish baseline parameters, 90-day treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of treatment response, and potential effects of EPI-589 therapy on known trajectory.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJan 2016
Primary CompletionFeb 2018
TodayJul 2026
First PostedJun 2, 2015
Enrollment StartJan 14, 2016
Primary CompletionFeb 23, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.1 years ago
Interventions
EPI-589drug
An immediate release film-coated table at a 250 mg dosage strength will be administered per dose and schedule specified in arm.