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Gene Therapy

Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy (REGAiN-1A 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

Male or female participants age ≥ 18 years at time of completion of the informed consent process

If on medication for painful DPN (other than gabapentin or pregabalin), must be on a stable dose defined as < 50% change in total dose over 3 months prior to completion of informed consent process

Must not have

Do you weigh more than 180 pounds?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

Pivotal Trial

Summary

This trial tests Engensis, a treatment given through muscle injections, on people with painful diabetic nerve damage in their feet and lower legs. Engensis aims to reduce pain by promoting the healing of nerve cells.

Eligible Conditions

Diabetic Neuropathy

Eligibility Criteria

Inclusion Criteria

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

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were randomized to either the intervention group or the delayed intervention group Male or female participants were randomized to either the intervention group or the delayed intervention group.

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If you are taking medication for DPN pain (other than gabapentin or pregabalin), your dose must be stable for the three months before you sign the consent form.

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Capable of following the instructions in the protocol and willing to comply with the requirements of the protocol, including signing the consent form.

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People who have type 1 or 2 diabetes mellitus and meet the following conditions: - Are on current Standards of Medical Care in Diabetes - 2020 optimal guideline-directed medical therapy - Do not have unstable diabetes or significant medical problems, such as progressive end-organ disease, within 3 months of or during Screening - Have a glycosylated hemoglobin A1c (HbA1c) of ≤ 10.0% using the first assessment collected during Screening - Are in the judgment of the Investigator will be eligible to participate in the study.

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Have you been diagnosed with Type 1 or Type 2 Diabetes? test

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Do you experience painful diabetic peripheral neuropathy?

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Have you been diagnosed with bilateral painful DPN in both lower extremities for at least six months?

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Engensis compared to Placebo on painful DPN in the feet and lower legs comparing the Average Daily Pain Score from the Day 0 Visit to the Day 180 Visit on the Brief Pain Inventory for Participants with Diabetic Peripheral Neuropathy

Secondary study objectives

Foot

Efficacy of Engensis on the worst pain in painful DPN in the feet and lower legs by comparing the change from baseline (Day 0) in the Worst Pain score from the Brief Pain Inventory for Diabetic Peripheral Neuropathy to Day 180 compared to Placebo

Safety of Engensis in painful DPN in the feet and lower legs by comparing the incidence of adverse and serious adverse events, the incidence of injection site reactions, and the incidence of clinically significant laboratory values to Placebo

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Other study objectives

To determine whether IM administration of Engensis has the potential for disease modification by measuring the improvement in Bedside Sensory Testing at Day 180 compared to Baseline

To determine whether IM administration of Engensis has the potential for improving quality of life, sensation, proprioception, and deep tendon reflexes by measuring the improvement in Bedside Sensory Testing at Day 180 compared to Baseline