Status:
COMPLETED
A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
Eligibility Criteria
Inclusion
- Participant has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female participants ≥18 years of age at the Screening Visit
- Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
- Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
- Pain from DPNP present for at least 6 months prior to Screening
- At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
- Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
- Willing to adhere to the prohibitions and restrictions specified in the protocol.
Exclusion
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
- Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT06203002
Start Date
November 29 2023
End Date
February 24 2025
Last Update
October 10 2025
Active Locations (108)
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1
Lexicon Investigational Site (128)
Anniston, Alabama, United States, 36207
2
Lexicon Investigational Site (222)
Birmingham, Alabama, United States, 35216
3
Lexicon Investigational Site (189)
Daphne, Alabama, United States, 36526
4
Lexicon Investigational Site (215)
Guntersville, Alabama, United States, 35976