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01
Overview
Phase 2, randomised, double-blind trial in amyotrophic lateral sclerosis (ALS) comparing Engensis with Placebo (2 arms). Primary endpoint: Safety of Intramuscular Injections of Engensis in Participants With Amyotrophic Lateral Sclerosis Compared to Placebo. Started Mar 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Engensis
64 mg Engensis per Treatment Cycle, with each of 3 cycles composed of 2 days of 128 injections each to the right and left target muscles, spaced 2 weeks apart
Placebo
32 mL of Placebo per Treatment Cycle, with each of 3 cycles composed of 2 days of 128 injections each to the right and left target muscles, spaced 2 weeks apart
03
Who it enrols
Adults with clinically definite or probable ALS with limb onset, symptom onset ≤4 years, SVC ≥50% predicted, stable riluzole/edaravone doses, no recent investigational ALS treatments or stem cell therapy
04
Endpoints
Primary
Safety of Intramuscular Injections of Engensis in Participants With Amyotrophic Lateral Sclerosis Compared to Placebo
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