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Virus Therapy

Engensis for Amyotrophic Lateral Sclerosis (REViVALS-1A Trial)

Phase 2
Waitlist Available
Research Sponsored by Helixmith Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84 to day 180
Awards & highlights

REViVALS-1A Trial Summary

This study is evaluating whether a drug may help treat amyotrophic lateral sclerosis.

Eligible Conditions
  • Amyotrophic Lateral Sclerosis

REViVALS-1A Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84 to day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 to day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amyotrophic Lateral Sclerosis
Other outcome measures
Changes in muscle function following Engensis injections compared to Placebo
Comparing gene expression differences in muscle atrophy biomarkers between subjects receiving Engensis and subjects receiving Placebo by using RNA sequencing
Evaluation of Patient and Clinical Reported Outcome improvement following Engensis injections compared to Placebo - CGIC
+7 more

REViVALS-1A Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EngensisActive Control1 Intervention
64 mg Engensis per Treatment Cycle, with each of 3 cycles composed of 2 days of 128 injections each to the right and left target muscles, spaced 2 weeks apart
Group II: PlaceboPlacebo Group1 Intervention
32 mL of Placebo per Treatment Cycle, with each of 3 cycles composed of 2 days of 128 injections each to the right and left target muscles, spaced 2 weeks apart

Find a Location

Who is running the clinical trial?

Helixmith Co., Ltd.Lead Sponsor
19 Previous Clinical Trials
1,615 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
26 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis
2021. "Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04632225.
~4 spots leftby Apr 2025
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