Evaluating a new treatment for diabetic nerve pain
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
This study is testing a new treatment called JMKX000623 to see if it can help people with diabetic nerve pain feel better compared to a placebo and another medication called pregabalin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jemincare Industry-sponsored |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06221241 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial aims to assess the efficacy and safety of JMKX000623 in patients suffering from diabetic peripheral neuropathic pain. The study is multicenter, randomized, and double-blind, comparing JMKX000623 against a placebo and the active drug pregabalin. Participants will be monitored for pain relief and any adverse effects over the course of the trial. The study seeks to provide insights into a potential new treatment option for this chronic condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with diabetic peripheral neuropathic pain for at least 24 weeks.
Not a fit: Patients with other types of peripheral neuropathies or those who have previously failed treatment with pregabalin or gabapentin may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain for patients with diabetic peripheral neuropathic pain.
How similar studies have performed: Other studies have shown promise in treating diabetic peripheral neuropathic pain with similar approaches, but the specific efficacy of JMKX000623 is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to understand the procedures of this trial and provide written informed consent voluntarily; 2. Age ≥ 18 years, male or female; 3. Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks; 4. Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9; 5. HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks. Exclusion Criteria: 1. With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain; 2. Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions; 3. Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial; 4. Known treatment failure on pregabalin or gabapentin;
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Lei Xing, PM
- Email: xinglei@jemincare.com
- Phone: 010-66119025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.