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COMPLETED Phase 2

Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis

NCT04632225 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2021-03-09
Est. Completion 2024-07-15
Phase Phase 2

Sponsor

Helixmith Co.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04632225

The ClinicalTrials.gov registry entry for NCT04632225 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helixmith Co., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04632225 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Arizona, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04632225?

The interventions under investigation include: Placebo (OTHER), Engensis (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04632225?

This trial is sponsored by Helixmith Co., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial