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

Sponsor
Lexicon Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04455633
Collaborator
(none)
319
Enrollment
45
Locations
3
Arms
23.7
Actual Duration (Months)
7.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: LX9211 low dose
  • Drug: LX9211 high dose
  • Drug: LX9211 Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
319 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 7, 2020
Actual Primary Completion Date :
May 23, 2022
Actual Study Completion Date :
Jun 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LX9211 low dose

LX9211, once daily

Drug: LX9211 low dose
11-week assessment period
Experimental: LX9211 high dose

LX9211, once daily

Drug: LX9211 high dose
11-week assessment period
Placebo Comparator: Placebo

Placebo, once daily

Drug: LX9211 Placebo
11-week assessment period

Outcome Measures

Primary Outcome Measures

  1. 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

  1. ≥30% reduction in pain intensity [Day 1 to Week 6]

    Proportion of patients with ≥30% reduction in pain intensity

  2. ≥50% reduction in pain intensity [Day 1 to Week 6]

    Proportion of patients with ≥50% reduction in pain intensity

  3. Safety: # of AEs reported [Day 1 to Week 6]

    # of Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lexicon Investigational Site Mobile Alabama United States 36608
2 Lexicon Investigational Site (156) Chandler Arizona United States 85286
3 Lexicon Investigational Site Glendale Arizona United States 85308
4 Lexicon Investigational Site (162) Kingman Arizona United States 86409
5 Lexicon Investigational Site Tucson Arizona United States 85741
6 Lexicon Investigational Site Anaheim California United States 92801
7 Lexicon Investigational Site Greenbrae California United States 94904
8 Lexicon Investigational Site (167) Los Angeles California United States 90026
9 Lexicon Investigational Site North Hollywood California United States 91606
10 Lexicon Investigational Site Sacramento California United States 95821
11 Lexicon Investigational Site Tustin California United States 92780
12 Lexicon Investigational Site (140) Brandon Florida United States 33511
13 Lexicon Investigational Site Fort Myers Florida United States 33912
14 Lexicon Investigational Site (154) Jacksonville Florida United States 32204
15 Lexicon Investigational Site (157) Lake City Florida United States 32055
16 Lexicon Investigational Site (166) Lake City Florida United States 32055
17 Lexicon Investigational Site New Port Richey Florida United States 34652
18 Lexicon Investigational Site Ormond Beach Florida United States 32174
19 Lexicon Investigational Site Winter Park Florida United States 32789
20 Lexicon Investigational Site (163) Macon Georgia United States 31210
21 Lexicon Investigational Site Evansville Indiana United States 47714
22 Lexicon Investigational Site Boston Massachusetts United States 02115
23 Lexicon Investigational Site South Dartmouth Massachusetts United States 02747
24 Lexicon Investigational Site Ann Arbor Michigan United States 48109
25 Lexicon Investigational Site (151) Dearborn Michigan United States 48124
26 Lexicon Investigational Site (150) Farmington Hills Michigan United States 48334
27 Lexicon Investigational Site (159) Sterling Heights Michigan United States 48312
28 Lexicon Investigational Site Hazelwood Missouri United States 63042
29 Lexicon Investigational Site Omaha Nebraska United States 68130
30 Lexicon Investigational Site Berlin New Jersey United States 08009
31 Lexicon Investigational Site Westfield New York United States 14787
32 Lexicon Investigational Site Williamsville New York United States 14221
33 Lexicon Investigational Site (153) Asheville North Carolina United States 28803
34 Lexicon Investigational Site Cary North Carolina United States 27518
35 Lexicon Investigational Site Morehead City North Carolina United States 28557
36 Lexicon Investigational Site (149) Greenville South Carolina United States 29607
37 Lexicon Investigational Site Austin Texas United States 78731
38 Lexicon Investigational Site Austin Texas United States 78749
39 Lexicon Investigational Site Dallas Texas United States 75231
40 Lexicon Investigational Site (168) Flower Mound Texas United States 75028
41 Lexicon Investigational Site Houston Texas United States 77030
42 Lexicon Investigational Site Houston Texas United States 77074
43 Lexicon Investigational Site Pearland Texas United States 77584
44 Lexicon Investigational Site Salt Lake City Utah United States 84107
45 Lexicon Investigational Site Renton Washington United States 98057

Sponsors and Collaborators

  • Lexicon Pharmaceuticals

Investigators

  • Study Director: Suman Wason, MD, Lexicon Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04455633
Other Study ID Numbers:
  • LX9211.1-201-DPN
  • LX9211.201
First Posted:
Jul 2, 2020
Last Update Posted:
Aug 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases

Study Results

No Results Posted as of Aug 15, 2022