Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

Inclusion Criteria:

• Patient has given written informed consent to participate in the study in accordance with local regulations

• Adult male and female patients ≥18 years of age at the time of screening

• Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening

• Diagnosis of DPNP at Screening

• Pain from DPN present for at least 6 months

• A1C ≤11% at screening

• Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening

Exclusion Criteria:

• 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 NSAIDs less than 2 weeks prior to the Screening Visit