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NCT04632225 · ClinicalTrials.gov registry record · Phase 2
Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 5
- Study locations
NCT04632225: Completed Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Helixmith Co..
NCT04632225 is a Phase 2 study of Amyotrophic Lateral Sclerosis that has completed, run by Helixmith Co.. The registered enrollment target is 18 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632225, a Phase 2 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study was to evaluate the safety of intramuscular administration of Engensis in Participants with Amyotrophic Lateral Sclerosis as compared to Placebo. Safety will be assessed by incidences of treatment-emergent adverse events, treatment-emergent serious adverse events, injection site reactions and other adverse events of special interest, and the clinically significant laboratory values after injections of Engensis compared to Placebo. Exploratory endpoints include assessment of muscle function using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale subscores for Fine and Gross Motor Function; muscle strength by quantitative testing using handheld dynamometry and the Accurate Test of Limb Isometric Strength where available; quality of life using the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40; patient global impression of change, clinical global impression of change, and clinical global impression of severity; and evaluation of lung function using Slow Vital Capacity. Muscle biopsies will be performed during the study for future biomarker analyses.
Primary Outcome
Incidence of treatment-emergent adverse events in more than or equal to 10% of subjects, and treatment-emergent serious adverse events after injections, injection site reactions, and clinically significant laboratory values for Engensis compared to Placebo.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Engensis
Study Locations (5)
Arizona
- St. Joseph's Hospital and Medical Center, Barrows Neurological Institute - Phoenix
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University Department of Neurology - Baltimore
Texas
- Austin Neuromuscular Center - Austin
Other
- Hanyang University Medical Center - Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 2 |
What the finished NCT04632225 record still lists
NCT04632225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04632225 lists 5 locations in 5 states (Arizona, Illinois, Maryland).
Frequently Asked Questions
What is clinical trial NCT04632225 about?
NCT04632225 is a clinical study titled "Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis". The purpose of this study was to evaluate the safety of intramuscular administration of Engensis in Participants with Amyotrophic Lateral Sclerosis as compared to Placebo. Safety will be assessed by incidences of treatment-emergent adverse events, treatment-emergent serious adverse events, injection...
What is the current status of trial NCT04632225?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-03-09. Estimated completion is 2024-07-15.
What conditions does trial NCT04632225 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT04632225?
The interventions under investigation include: Placebo (OTHER), Engensis (BIOLOGICAL).
Who is sponsoring clinical trial NCT04632225?
This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04632225 being conducted?
This trial has 5 study locations across Arizona, Illinois, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04632225's enrollment target sits among peer trials
18 82nd of 102 higher than 20 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis 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.
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