A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy (REGAiN-1B)
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- STATUS
- Recruiting
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- End date
- Dec 20, 2023
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- participants needed
- 250
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- sponsor
- Helixmith Co., Ltd.
Summary
To evaluate the durability of efficacy and long-term safety of intramuscular (IM) administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.
Description
The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular (IM) administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study. No treatments will be administered in this VMDN-003-2b extension study. The combined overall duration of the VMDN-003-2 and VMDN-003-2b studies will be 12 months.
Participants will be enrolled in the VMDN-003-2b study at completion of the Day 180 Visit of Study VMDN-003-2. Participants will continue to be identified by the same Participant number and the same treatment group (Engensis or Placebo) assigned by randomization in Study VMDN-003-2. No study drug or treatment will be administered in this VMDN-003-2b extension study. The double-blind treatment assignment from the prior study will be maintained for Investigators and Participants during this extension study.
This extension study will assess the durability of efficacy and long-term safety of Engensis compared to Placebo as measured by changes in Average Daily Pain Score (ADPS) of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Bedside Sensory Testing (BST), physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs).
Details
| Condition | Diabetic Peripheral Neuropathy |
|---|---|
| Treatment | Placebo, Engensis |
| Clinical Study Identifier | NCT04873232 |
| Sponsor | Helixmith Co., Ltd. |
| Last Modified on | 4 October 2022 |
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