Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Helixmith Co.. The registered enrollment target is 8 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05176093
The ClinicalTrials.gov registry entry for NCT05176093 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helixmith Co., which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05176093 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.