NCT05176093CompletedPhase 2
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 5 Nov 2021
- Start date
- 14 Nov 2021
- Primary completion date
- 29 Dec 2022
- Lead sponsor
- Helixmith Co., Ltd.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05176093
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 8
- From 14 Nov 2021 to the primary completion date, 29 Dec 2022
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- None
Who the study is looking for
- Participants who complete the Day 180 Visit in VMALS-002-2 are eligible to enroll in this extension study, VMALS-002-2b.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hanyang University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Austin Neuromuscular Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.