Status:
COMPLETED
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Diabetic Peripheral Neuropathy
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
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 time of screening
- Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
- Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
- Pain from DPN present for at least 6 months
- Haemoglobin A1C ≤11% at screening
- Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening
Exclusion
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of major depressive episode, active, significant psychiatric disorders
- History of clinically significant drug or alcohol use disorder
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT04455633
Start Date
September 3 2020
End Date
June 28 2022
Last Update
June 25 2025
Active Locations (44)
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1
Lexicon Investigational Site
Mobile, Alabama, United States, 36608
2
Lexicon Investigational Site
Chandler, Arizona, United States, 85286
3
Lexicon Investigational Site
Glendale, Arizona, United States, 85308
4
Lexicon Investigational Site
Kingman, Arizona, United States, 86409