Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy (REGAiN-1A)
An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Engensis in Participants With Painful Diabetic Peripheral Neuropathy
Sponsor: Helixmith Co., Ltd.
Listed as NCT04469270, this PHASE3 trial focuses on Diabetic Neuropathy, Painful and remains completed. Sponsored by Helixmith Co., Ltd., it has been updated 13 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
13 versions recorded-
Nov 2025 — Present [monthly]
Completed PHASE3
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Feb 2025 — Nov 2025 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Sep 2024 — Feb 2025 [monthly]
Active Not Recruiting PHASE3
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE3
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Dec 2022 — Jul 2024 [monthly]
Active Not Recruiting PHASE3
▶ Show 8 earlier versions
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Sep 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Dec 2021 — Sep 2022 [monthly]
Recruiting PHASE3
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Sep 2021 — Dec 2021 [monthly]
Recruiting PHASE3
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Jun 2021 — Sep 2021 [monthly]
Recruiting PHASE3
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Feb 2021 — Jun 2021 [monthly]
Recruiting PHASE3
-
Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE3
-
Dec 2020 — Jan 2021 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Aug 2020 — Dec 2020 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Helixmith Co., Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .