REGAiN-1B: A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Engensis Patients who have received Engensis in protocol VMDN-003-2 |
Biological: Engensis
Injections with Engensis in study VMDN-003-2
|
| Placebo Comparator: Placebo Patients who have received Placebo in protocol VMDN-003-2 |
Other: Placebo
Injections with Placebo in study VMDN-003-2
|
Outcome Measures
Primary Outcome Measures
- 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 [From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to 7 days prior to the Day 365 Visit]
Change in the means of the Average Daily Pain Scores (ADPSs) from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome.
Secondary Outcome Measures
- 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 [From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit]
Change in the means of the Worst Pain scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome.
- To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs [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]
Proportion of Responders (>=50% reduction in the ADPSs from the full BPI-DPN)
- To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs [Day 0 to Day 365]
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and clinically significant laboratory values
Eligibility Criteria
Criteria
Inclusion Criteria:
- Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Research Center | Phoenix | Arizona | United States | 85053 |
| 2 | Clinical Trials - Little Rock | Little Rock | Arkansas | United States | 72205 |
| 3 | California Medical Clinic for Headache | Los Angeles | California | United States | 90048 |
| 4 | Clinical Trials Research - Sacramento | Sacramento | California | United States | 95821 |
| 5 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
| 6 | Clinical Research Professionals | Chesterfield | Missouri | United States | 63005 |
| 7 | Richmond Behavioral Associates | Staten Island | New York | United States | 10314 |
| 8 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 9 | Nerve and Muscle Center of Texas | Houston | Texas | United States | 77030 |
| 10 | ClinPoint Trials LLC | Waxahachie | Texas | United States | 75165 |
| 11 | Manassas Clinical Research Center | Manassas | Virginia | United States | 20110 |
| 12 | Eastern Virginia Medical School | Norfolk | Virginia | United States | 23510 |
| 13 | Dominion Medical Associates | Richmond | Virginia | United States | 23219 |
Sponsors and Collaborators
- Helixmith Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VMDN-003-2b