At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
AXER-204 +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 Multicenter, Two Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AXER-204 in Subjects With Chronic Spinal Cord Injury
In Brief
A Phase 2 clinical trial evaluating AXER-204 and Placebo for Chronic Spinal Cord Injury. Completed, enrolled 52 participants across 6 sites.
Detailed Summary
This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion. Part 1 will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of AXER-204. Part 2 will evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 in comparison to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spinal Cord Injury
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJul 2019
Primary CompletionJun 2022
TodayJul 2026
First PostedJun 18, 2019
Enrollment StartJul 16, 2019
Primary CompletionJun 21, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.0 years ago
Interventions
AXER-204drug
human NoGo Trap fusion protein
Placebodrug
Phosphate buffered saline formulation