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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 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 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