A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT05176093

Run by

Helixmith Co., Ltd.

People needed

8

Starts

2021-11-14

Expected to finish

2024-08-23

Last updated by the study team

2025-10-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who complete the Day 180 Visit in VMALS-002-2 are eligible to enroll in this extension study, VMALS-002-2b.

You may not qualify if…

• None

Where it is running

• Austin Neuromuscular Center — Austin, Texas, United States
• Hanyang University Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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