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NEW Diabetes and Pain Medication Study
Study Summary
This trial will test treatments for painful diabetic nerve pain. It's part of the NIH's HEAL Initiative.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Media Library
- I have Type 2 Diabetes.I have diabetic neuropathy.I have had a heart attack or stroke.I experience pain in my legs, feet, toes, or ankles.My diabetes treatment has been stable for at least 3 months with no expected changes.
- Group 1: EN21-01 ISA
- Group 2: Placebo Comparator
- Screening: It may take up to 45 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 107 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still slots available for participants in this experiment?
"This medical trial can be found on clinicaltrials.gov and is actively seeking participants. It was first published on September 21st, 2022 with the most recent update occurring February 6th, 2023."
How many locations have been approved for the management of this research study?
"Potential participants in this trial can be found at South Lake Pain Institute, Clermont; the University of Florida, Gainesville; Mount Sinai School of Medicine, New york and Washington. Additionally, there are 7 other clinical centres involved in this study."
How many participants are contributing to this research project?
"This clinical trial necessitates 122 patients with appropriate inclusion criteria. There are multiple locations that can be utilised for enrollment, such as the South Lake Pain Institute in Clermont, Florida and the University of Florida in Gainesville, New york."
Has EN21-01 ISA attained clearance from the FDA?
"Our team at Power believes EN21-01 ISA is relatively safe, scoring it a 2 on the safety scale. This assessment was made due to being a Phase 2 trial with some evidence of security, but no proof that this medication works effectively."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- University of Rochester: < 24 hours
- MGH Department of Anesthesia, Critical Care, and Pain: < 24 hours
- University of Wisconsin: < 24 hours
Average response time
- < 2 Days
Typically responds via
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