At a glance
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A 6-Month Extension Study Following Protocol VMALS-002-2 (A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis)
In Brief
A Phase 2 clinical trial evaluating Engensis and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 8 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Lyophilized biologic to be reconstituted containing Engensis
Injectable Liquid