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

Diabetes Clinical Trial

— RELIEF-DPN 1  

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455633
• Other study ID #: LX9211.1-201-DPN
• Secondary ID: LX9211.201
• Status: Completed
• Phase: Phase 2
• Start date: July 7, 2020
• Est. completion date: June 28, 2022

Study information

• Verified date: May 2023
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: June 28, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Peripheral Neuropathy
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• LX9211 low dose
11-week assessment period
• LX9211 high dose
11-week assessment period
• LX9211 Placebo
11-week assessment period

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Anaheim	California
United States	Lexicon Investigational Site	Ann Arbor	Michigan
United States	Lexicon Investigational Site (153)	Asheville	North Carolina
United States	Lexicon Investigational Site	Austin	Texas
United States	Lexicon Investigational Site	Austin	Texas
United States	Lexicon Investigational Site	Berlin	New Jersey
United States	Lexicon Investigational Site	Boston	Massachusetts
United States	Lexicon Investigational Site (140)	Brandon	Florida
United States	Lexicon Investigational Site	Cary	North Carolina
United States	Lexicon Investigational Site (156)	Chandler	Arizona
United States	Lexicon Investigational Site	Dallas	Texas
United States	Lexicon Investigational Site (151)	Dearborn	Michigan
United States	Lexicon Investigational Site	Evansville	Indiana
United States	Lexicon Investigational Site (150)	Farmington Hills	Michigan
United States	Lexicon Investigational Site (168)	Flower Mound	Texas
United States	Lexicon Investigational Site	Fort Myers	Florida
United States	Lexicon Investigational Site	Glendale	Arizona
United States	Lexicon Investigational Site	Greenbrae	California
United States	Lexicon Investigational Site (149)	Greenville	South Carolina
United States	Lexicon Investigational Site	Hazelwood	Missouri
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site (154)	Jacksonville	Florida
United States	Lexicon Investigational Site (162)	Kingman	Arizona
United States	Lexicon Investigational Site (157)	Lake City	Florida
United States	Lexicon Investigational Site (166)	Lake City	Florida
United States	Lexicon Investigational Site (167)	Los Angeles	California
United States	Lexicon Investigational Site (163)	Macon	Georgia
United States	Lexicon Investigational Site	Mobile	Alabama
United States	Lexicon Investigational Site	Morehead City	North Carolina
United States	Lexicon Investigational Site	New Port Richey	Florida
United States	Lexicon Investigational Site	North Hollywood	California
United States	Lexicon Investigational Site	Omaha	Nebraska
United States	Lexicon Investigational Site	Ormond Beach	Florida
United States	Lexicon Investigational Site	Pearland	Texas
United States	Lexicon Investigational Site	Renton	Washington
United States	Lexicon Investigational Site	Sacramento	California
United States	Lexicon Investigational Site	Salt Lake City	Utah
United States	Lexicon Investigational Site	South Dartmouth	Massachusetts
United States	Lexicon Investigational Site (159)	Sterling Heights	Michigan
United States	Lexicon Investigational Site	Tucson	Arizona
United States	Lexicon Investigational Site	Tustin	California
United States	Lexicon Investigational Site	Westfield	New York
United States	Lexicon Investigational Site	Williamsville	New York
United States	Lexicon Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Average Daily Pain Score (ADPS)	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])	Day 1 to Week 6
Secondary	=30% reduction in pain intensity	Proportion of patients with =30% reduction in pain intensity	Day 1 to Week 6
Secondary	=50% reduction in pain intensity	Proportion of patients with =50% reduction in pain intensity	Day 1 to Week 6
Secondary	Safety: # of AEs reported	# of Adverse Events	Day 1 to Week 6