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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

REViVALS-1B Trial Summary

This trial is looking at the long-term safety of a medication given to people with ALS. They will assess side effects, serious side effects, and any changes in laboratory values.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

REViVALS-1B Trial Eligibility Criteria

Inclusion Criteria

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

REViVALS-1B Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
• To evaluate the long-term safety of intramuscular (IM) injections of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS)
Other outcome measures
• 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

REViVALS-1B 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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still admitting participants?

"According to clinicaltrials.gov, this medical trial has concluded recruitment and is no longer searching for candidates; the study was first posted on November 14th 2021 before being updated most recently on November 3rd 2022. Thankfully, there are 539 other trials currently seeking participants at present."

Answered by AI

Am I eligible to enrol in this trial?

"Prospective trial participants must have amyotrophic lateral sclerosis and be between 18 to 80 years old. This medical study is accepting up to 18 individuals in total."

Answered by AI

Has the FDA approved Engensis for medical use?

"The safety of Engensis is estimated at a score of 2 because it has only reached Phase 2 and there are no data that suggest its efficacy."

Answered by AI

Are individuals aged under fifty acceptable participants for this experiment?

"This research endeavour is looking for participants aged between 18 and 80 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
2021. "A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176093.
~2 spots leftby Apr 2025
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