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

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathy; Diabetes
• Interventions: Drug: LX9211 high dose; Drug: LX9211 Placebo; Drug: LX9211 low dose

• Registration Number: NCT04455633
• Lead Sponsor: Lexicon Pharmaceuticals

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 over an 11 week assessment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Study Start: 2020-07-07
• Primary Completion: 2022-05-23
• Study Completion: 2022-06-28
• Status Verified: 2023-05
• Disposition First Submitted: 2023-05-22
• Last Update Submitted: 2023-05-22
• Disposition First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LX9211 high dose	LX9211 high dose	LX9211, once daily
Placebo	LX9211 Placebo	Placebo, once daily
LX9211 low dose	LX9211 low dose	LX9211, once daily

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Average Daily Pain Score (ADPS)	Day 1 to Week 6	The change from Baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS) (0 \[no pain\] to 10 \[worst imaginable pain\])

Secondary Outcome Measures

Name	Time	Method
Safety: # of AEs reported	Day 1 to Week 6	# of Adverse Events
≥50% reduction in pain intensity	Day 1 to Week 6	Proportion of patients with ≥50% reduction in pain intensity
≥30% reduction in pain intensity	Day 1 to Week 6	Proportion of patients with ≥30% reduction in pain intensity

Trial Locations

Locations (15)

Lexicon Investigational Site (156); 🇺🇸 Chandler, Arizona, United States

Lexicon Investigational Site (162); 🇺🇸 Kingman, Arizona, United States

Lexicon Investigational Site (149); 🇺🇸 Greenville, South Carolina, United States

Lexicon Investigational Site (168); 🇺🇸 Flower Mound, Texas, United States

Lexicon Investigational Site; 🇺🇸 Renton, Washington, United States

Lexicon Investigational Site (154); 🇺🇸 Jacksonville, Florida, United States

Lexicon Investigational Site (140); 🇺🇸 Brandon, Florida, United States

Lexicon Investigational Site (157); 🇺🇸 Lake City, Florida, United States

Lexicon Investigational Site (151); 🇺🇸 Dearborn, Michigan, United States

Lexicon Investigational Site (167); 🇺🇸 Los Angeles, California, United States

Lexicon Investigational Site (163); 🇺🇸 Macon, Georgia, United States

Lexicon Investigational Site (150); 🇺🇸 Farmington Hills, Michigan, United States

Lexicon Investigational Site (159); 🇺🇸 Sterling Heights, Michigan, United States

Lexicon Investigational Site (153); 🇺🇸 Asheville, North Carolina, United States

Lexicon Investigational Site (166); 🇺🇸 Lake City, Florida, United States