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

NCT06221241 | Recruiting Phase 2 DMC

• 1 other identifier: JMKX0623-201
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)]

  baseline，Week 5

• Adverse Events

  baseline，Week 12

Study Arms (3)

JMKX000623

EXPERIMENTAL

JMKX000623 for 12 weeks

Drug: JMKX000623; Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

Pregabalin for 12 weeks

Drug: Pregabalin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

placebo for 12 weeks

Drug: Placebo

Interventions

JMKX000623 DRUG

tablets for oral administration.

JMKX000623

Pregabalin DRUG

capsules for oral administration.

Pregabalin

Placebo DRUG

matched to JMKX000623 and Pregabalin

JMKX000623; Placebo; Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the procedures of this trial and provide written informed consent voluntarily;
• Age ≥ 18 years, male or female;
• Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
• Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
• HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.

You may not qualify if:

• With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
• Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
• Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
• Known treatment failure on pregabalin or gabapentin;

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Lei Xing, PM

CONTACT

010-66119025; xinglei@jemincare.com

Xiaohui Guo, MD

CONTACT

010-66119025

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 24, 2024
• Study Start: March 25, 2024
• Primary Completion: March 14, 2025
• Study Completion: April 30, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)