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

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)
Amyotrophic Lateral Sclerosis

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 365

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

0 / 1Eligibility criteria met