Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic 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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: JMKX000623; Drug: Placebo; Drug: Pregabalin

Detailed Description

Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Xing, PM; Phone Number: 010-66119025; Email: xinglei@jemincare.com
• Study Contact Backup: Name: Xiaohui Guo, MD; Phone Number: 010-66119025

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Lei Xing, PM; Phone Number: 010-66119025; Email: xinglei@jemincare.com
      • Contact: Xiaohui Guo, MD; Phone Number: 010-66119025; Email: xinglei@jemincare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JMKX000623; JMKX000623 for 12 weeks	Drug: JMKX000623; tablets for oral administration.; Drug: Placebo; matched to JMKX000623 and Pregabalin
Active Comparator: Pregabalin; Pregabalin for 12 weeks	Drug: Placebo; matched to JMKX000623 and Pregabalin; Drug: Pregabalin; capsules for oral administration.
Placebo Comparator: Placebo; placebo for 12 weeks	Drug: Placebo; matched to JMKX000623 and Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]	baseline，Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]	baseline，Week 5
Adverse Events		baseline，Week 12

Collaborators and Investigators

• Sponsor: Jemincare

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: JMKX0623-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No