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Virus Therapy

Engensis for Amyotrophic Lateral Sclerosis (REViVALS-1B 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
* Participants who complete the Day 180 Visit in VMALS-002-2 are eligible to enroll in this extension study, VMALS-002-2b.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 365
Awards & highlights

Summary

This trial is studying the safety of Engensis, a treatment given through muscle injections, in ALS patients. The goal is to see if there are any side effects or serious issues over time.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
• To evaluate the long-term safety of intramuscular (IM) injections of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS)
Other study objectives
• To determine whether IM administration of Engensis has effects on respiratory capacity in ALS Participants
• To determine whether IM administration of Engensis has effects on respiratory function in ALS Participants
• To determine whether IM administration of Engensis has positive effects on survival in ALS Participants
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EngensisActive Control1 Intervention
Active Comparator: Engensis 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
Placebo Comparator: Placebo 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

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Who is running the clinical trial?

Helixmith Co., Ltd.Lead Sponsor
19 Previous Clinical Trials
1,625 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
36 Patients Enrolled for Amyotrophic Lateral Sclerosis
~2 spots leftby Sep 2025
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