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NCT05176093 · ClinicalTrials.gov registry record · Phase 2
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
A Phase 2 study, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT05176093: Completed Phase 2 study, sponsored by Helixmith Co..
NCT05176093 is a Phase 2 study that has completed, run by Helixmith Co.. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05176093, a Phase 2 study, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the long-term safety of intramuscular injections of Engensis in Participants with Amyotrophic Lateral Sclerosis in more than 2 Participants by System Organ Class and Preferred Term (Safety Analysis Population)
Interventions
- OTHER Placebo
- BIOLOGICAL Engensis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-11-14 |
| Est. Completion | 2024-08-23 |
| Phase | Phase 2 |
What the finished NCT05176093 record still lists
NCT05176093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05176093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05176093 about?
NCT05176093 is a clinical study titled "A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis". 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...
What is the current status of trial NCT05176093?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2021-11-14. Estimated completion is 2024-08-23.
What interventions are being tested in trial NCT05176093?
The interventions under investigation include: Placebo (OTHER), Engensis (BIOLOGICAL).
Who is sponsoring clinical trial NCT05176093?
This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05176093's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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