A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) (PROGRESS)

April 4, 2024 updated by: Lexicon Pharmaceuticals

A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)

Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

416

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • Lexicon Investigational Site (128)
      • Daphne, Alabama, United States, 36526
        • Recruiting
        • Lexicon Investigational Site (189)
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Lexicon Investigational Site (102)
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Lexicon Investigational Site (107)
      • Fresno, California, United States, 93710
        • Recruiting
        • Lexicon Investigational Site (161)
      • Greenbrae, California, United States, 94904
        • Recruiting
        • Lexicon Investigational Site (112)
      • Lafayette, California, United States, 94549
        • Recruiting
        • Lexicon Investigational Site (171)
      • Sacramento, California, United States, 95821
        • Recruiting
        • Lexicon Investigational Site (126)
      • Sacramento, California, United States, 95821
        • Recruiting
        • Lexicon Investigational Site (111)
      • Tustin, California, United States, 92780
        • Recruiting
        • Lexicon Investigational Site (124)
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Lexicon Investigational Site (119)
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Lexicon Investigational Site (109)
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Lexicon Investigational Site (180)
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Lexicon Investigational Site (105)
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Lexicon Investigational Site (123)
      • The Villages, Florida, United States, 32159
        • Recruiting
        • Lexicon Investigational Site (133)
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Lexicon Investigational Site (103)
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • Lexicon Investigational Site (136)
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Recruiting
        • Lexicon Investigational Site (132)
    • Kansas
      • Newton, Kansas, United States, 67114
        • Recruiting
        • Lexicon Investigational Site (178)
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • Lexicon Investigational Site (186)
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • Lexicon Investigational Site (190)
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Lexicon Investigational Site (108)
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Recruiting
        • Lexicon Investigational Site (104)
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • Lexicon Investigational Site (174)
    • New York
      • Westfield, New York, United States, 14787
        • Recruiting
        • Lexicon Investigational Site (122)
      • Williamsville, New York, United States, 14221
        • Recruiting
        • Lexicon Investigational Site (110)
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lexicon Investigational Site (106)
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Lexicon Investigational Site (145)
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Lexicon Investigational Site (148)
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lexicon Investigational Site (183)
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Lexicon Investigational Site (113)
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Lexicon Investigational Site (120)
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Recruiting
        • Lexicon Investigational Site (101)
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Lexicon Investigational Site (130)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant has given written informed consent to participate in the study in accordance with local regulations
  2. Adult male and female participants ≥18 years of age at the Screening Visit
  3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening
  4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
  5. Pain from DPNP present for at least 6 months prior to Screening
  6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
  7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
  8. Willing to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion Criteria:

  1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
  2. History of neurolytic or neurosurgical therapy for DPNP
  3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
  4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
  5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LX9211 Low Dose
LX9211 low dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 (blinded) tablets
Experimental: LX9211 High Dose
LX9211 high dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 (blinded) tablets
Experimental: LX9211 High Dose Followed by Low Dose
LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 (blinded) tablets
Placebo Comparator: LX9211 Placebo
LX9211 matching placebo, orally, once daily during a blinded treatment period.
Drug: Placebo (blinded)
LX9211 matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
Time Frame: Baseline, Week 8
ADPS is based on the 11-point numerical rating scale (NRS) [0 (no pain) to 10 (worst imaginable pain)].
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 8 in Burning Pain
Time Frame: Baseline, Week 8
Burning pain is based on the 11-point NRS (0 [no burning] to 10 [worst burning imaginable]).
Baseline, Week 8
Change from Baseline to Week 8 in Pain Interference on Sleep
Time Frame: Baseline, Week 8
Pain interference on sleep is based on the 11-point NRS (0 [does not interfere] to 10 [completely interferes]).
Baseline, Week 8
Patient Global Impression of Change (PGIC) Score at Week 8
Time Frame: Week 8
The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse.
Week 8
Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score
Time Frame: Baseline, Week 8
NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexicon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX9211.1-204-DPN
  • LX9211.204-DPN (Other Identifier: Lexicon Pharmaceuticals, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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