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Gene Therapy
Engensis for Painful Diabetic Peripheral Neuropathy (REGAiN-1B Trial)
Phase 3
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 from the 7 days prior to the day 0 visit (study vmdn-003-2) to the 7 days prior to the day 270 visit and the 7 days prior to the day 365 visit
Awards & highlights
Pivotal Trial
Summary
This trial is studying the effects and safety of Engensis, a muscle injection treatment, for patients with Diabetic Peripheral Neuropathy, who suffer from chronic nerve pain due to diabetes. The goal is to see if Engensis can provide lasting pain relief and improve nerve function.
Eligible Conditions
- Diabetic Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the 7 days prior to the day 0 visit (study vmdn-003-2) to the 7 days prior to the day 270 visit and the 7 days prior to the day 365 visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the 7 days prior to the day 0 visit (study vmdn-003-2) to the 7 days prior to the day 270 visit and the 7 days prior to the day 365 visit
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 efficacy of IM administration of Engensis on pain in Participants with painful DPN in the feet and lower legs as compared to Placebo
Secondary study objectives
To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs
To evaluate the efficacy of IM administration of Engensis on the worst pain in Participants with painful DPN in the feet and lower legs as compared to Placebo
To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EngensisExperimental Treatment1 Intervention
Patients who have received Engensis in protocol VMDN-003-2
Group II: PlaceboPlacebo Group1 Intervention
Patients who have received Placebo in protocol VMDN-003-2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Engensis
2021
Completed Phase 2
~30
Who is running the clinical trial?
Helixmith Co., Ltd.Lead Sponsor
19 Previous Clinical Trials
1,380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There are no specific exclusion criteria for this study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Engensis
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT04873232 — Phase 3