Phase 2
Completed N=8
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov NCT05176093 ↗Enrolled (actual)
8
Serious AEs
25.0%
Results posted
May 2025
Primary outcomePrimary: Treatment-Emergent Adverse Events in More Than 2 Subjects Overall by System Organ Class and Preferred Term — 3; 3; 0; 2 Participants
Summary
The purpose of this study is to evaluate the long-term safety of intramuscular administration of Engensis in Participants with Amyotrophic Lateral Sclerosis who were previously randomized, received treatment, and completed the Day 180 Visit of Study VMALS-002-2. Safety will be assessed by incidences of treatment-emergent adverse events, treatment emergent serious adverse events, adverse events of special interest, and the clinically significant laboratory values.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-Emergent Adverse Events in More Than 2 Subjects Overall by System Organ Class and Preferred Term |
3; 3; 0; 2; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who complete the Day 180 Visit in VMALS-002-2 are eligible to enroll in this extension study, VMALS-002-2b.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05176093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.