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Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)

Primary Purpose

Diabetic Peripheral Neuropathy, Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LX9211 low dose
LX9211 high dose
LX9211 Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lexicon Investigational Site
  • Lexicon Investigational Site (156)
  • Lexicon Investigational Site
  • Lexicon Investigational Site (162)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (167)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (140)
  • Lexicon Investigational Site
  • Lexicon Investigational Site (154)
  • Lexicon Investigational Site (157)
  • Lexicon Investigational Site (166)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (163)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (151)
  • Lexicon Investigational Site (150)
  • Lexicon Investigational Site (159)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (153)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (149)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (168)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LX9211 low dose

LX9211 high dose

Placebo

Arm Description

LX9211, once daily

LX9211, once daily

Placebo, once daily

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

≥30% reduction in pain intensity
Proportion of patients with ≥30% reduction in pain intensity
≥50% reduction in pain intensity
Proportion of patients with ≥50% reduction in pain intensity
Safety: # of AEs reported
# of Adverse Events

Full Information

First Posted
June 29, 2020
Last Updated
May 22, 2023
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04455633
Brief Title
Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LX9211 low dose
Arm Type
Experimental
Arm Description
LX9211, once daily
Arm Title
LX9211 high dose
Arm Type
Experimental
Arm Description
LX9211, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, once daily
Intervention Type
Drug
Intervention Name(s)
LX9211 low dose
Intervention Description
11-week assessment period
Intervention Type
Drug
Intervention Name(s)
LX9211 high dose
Intervention Description
11-week assessment period
Intervention Type
Drug
Intervention Name(s)
LX9211 Placebo
Intervention Description
11-week assessment period
Primary Outcome Measure Information:
Title
Change from Baseline in Average Daily Pain Score (ADPS)
Description
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])
Time Frame
Day 1 to Week 6
Secondary Outcome Measure Information:
Title
≥30% reduction in pain intensity
Description
Proportion of patients with ≥30% reduction in pain intensity
Time Frame
Day 1 to Week 6
Title
≥50% reduction in pain intensity
Description
Proportion of patients with ≥50% reduction in pain intensity
Time Frame
Day 1 to Week 6
Title
Safety: # of AEs reported
Description
# of Adverse Events
Time Frame
Day 1 to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suma Gopinathan, PhD
Organizational Affiliation
Lexicon Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Lexicon Investigational Site (156)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85286
Country
United States
Facility Name
Lexicon Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Lexicon Investigational Site (162)
City
Kingman
State/Province
Arizona
ZIP/Postal Code
86409
Country
United States
Facility Name
Lexicon Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Lexicon Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Lexicon Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Lexicon Investigational Site (167)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Facility Name
Lexicon Investigational Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Lexicon Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Lexicon Investigational Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Lexicon Investigational Site (140)
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Lexicon Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Lexicon Investigational Site (154)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Lexicon Investigational Site (157)
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Lexicon Investigational Site (166)
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Lexicon Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Lexicon Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Lexicon Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Lexicon Investigational Site (163)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Lexicon Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Lexicon Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lexicon Investigational Site
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Lexicon Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Lexicon Investigational Site (151)
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Lexicon Investigational Site (150)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Lexicon Investigational Site (159)
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Lexicon Investigational Site
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Lexicon Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Lexicon Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Lexicon Investigational Site
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Lexicon Investigational Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Lexicon Investigational Site (153)
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Lexicon Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Lexicon Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lexicon Investigational Site (149)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Lexicon Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lexicon Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Lexicon Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Lexicon Investigational Site (168)
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Facility Name
Lexicon Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lexicon Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Lexicon Investigational Site
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Lexicon Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Lexicon Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35257579
Citation
Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.
Results Reference
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Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain

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