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

Diabetic Peripheral Neuropathic Pain Clinical Trial

— PROGRESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203002
• Other study ID #: LX9211.1-204-DPN
• Secondary ID: LX9211.204-DPN
• Status: Recruiting
• Phase: Phase 2
• Start date: November 29, 2023
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Lexicon Pharmaceuticals
• Contact: Tracy Newbold
• Phone: +1 (281) 863-3016
• Email: tnewbold[@]lexpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• Placebo (blinded)
LX9211 matching placebo tablets
• LX9211 (blinded)
LX9211 (blinded) tablets

Locations

Country	Name	City	State
United States	Lexicon Investigational Site (107)	Anaheim	California
United States	Lexicon Investigational Site (128)	Anniston	Alabama
United States	Lexicon Investigational Site (119)	Brandon	Florida
United States	Lexicon Investigational Site (183)	Charleston	South Carolina
United States	Lexicon Investigational Site (193)	Dallas	Texas
United States	Lexicon Investigational Site (189)	Daphne	Alabama
United States	Lexicon Investigational Site (177)	Daytona Beach	Florida
United States	Lexicon Investigational Site (108)	Dearborn	Michigan
United States	Lexicon Investigational Site (185)	El Dorado	Kansas
United States	Lexicon Investigational Site (187)	Eugene	Oregon
United States	Lexicon Investigational Site (132)	Flossmoor	Illinois
United States	Lexicon Investigational Site (114)	Flower Mound	Texas
United States	Lexicon Investigational Site (109)	Fort Myers	Florida
United States	Lexicon Investigational Site (161)	Fresno	California
United States	Lexicon Investigational Site (112)	Greenbrae	California
United States	Lexicon Investigational Site (113)	Greenville	South Carolina
United States	Lexicon Investigational Site (196)	Harlingen	Texas
United States	Lexicon Investigational Site (104)	Hazelwood	Missouri
United States	Lexicon Investigational Site (180)	Hollywood	Florida
United States	Lexicon Investigational Site (120)	Houston	Texas
United States	Lexicon Investigational Site (188)	Jacksonville	Florida
United States	Lexicon Investigational Site (174)	Kansas City	Missouri
United States	Lexicon Investigational Site (171)	Lafayette	California
United States	Lexicon Investigational Site (162)	Las Vegas	Nevada
United States	Lexicon Investigational Site (155)	Lewisville	Texas
United States	Lexicon Investigational Site (163)	Lomita	California
United States	Lexicon Investigational Site (169)	Long Beach	California
United States	Lexicon Investigational Site (130)	Manassas	Virginia
United States	Lexicon Investigational Site (151)	Marietta	Georgia
United States	Lexicon Investigational Site (160)	Memphis	Tennessee
United States	Lexicon Investigational Site (164)	Miami	Florida
United States	Lexicon Investigational Site (106)	Morehead City	North Carolina
United States	Lexicon Investigational Site (190)	New Orleans	Louisiana
United States	Lexicon Investigational Site (105)	New Port Richey	Florida
United States	Lexicon Investigational Site (178)	Newton	Kansas
United States	Lexicon Investigational Site (148)	Norman	Oklahoma
United States	Lexicon Investigational Site (139)	Olive Branch	Mississippi
United States	Lexicon Investigational Site (144)	Orlando	Florida
United States	Lexicon Investigational Site (146)	Orlando	Florida
United States	Lexicon Investigational Site (123)	Ormond Beach	Florida
United States	Lexicon Investigational Site (111)	Sacramento	California
United States	Lexicon Investigational Site (126)	Sacramento	California
United States	Lexicon Investigational Site (101)	Salt Lake City	Utah
United States	Lexicon Investigational Site (184)	Springfield	Missouri
United States	Lexicon Investigational Site (157)	Summerville	South Carolina
United States	Lexicon Investigational Site (133)	The Villages	Florida
United States	Lexicon Investigational Site (102)	Tucson	Arizona
United States	Lexicon Investigational Site (124)	Tustin	California
United States	Lexicon Investigational Site (122)	Westfield	New York
United States	Lexicon Investigational Site (186)	Wichita	Kansas
United States	Lexicon Investigational Site (110)	Williamsville	New York
United States	Lexicon Investigational Site (145)	Winston-Salem	North Carolina
United States	Lexicon Investigational Site (131)	Winter Haven	Florida
United States	Lexicon Investigational Site (103)	Winter Park	Florida
United States	Lexicon Investigational Site (136)	Woodstock	Georgia

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 to Week 8 in Average Daily Pain Score (ADPS)	ADPS is based on the 11-point numerical rating scale (NRS) [0 (no pain) to 10 (worst imaginable pain)].	Baseline, Week 8
Secondary	Change from Baseline to Week 8 in Burning Pain	Burning pain is based on the 11-point NRS (0 [no burning] to 10 [worst burning imaginable]).	Baseline, Week 8
Secondary	Change from Baseline to Week 8 in Pain Interference on Sleep	Pain interference on sleep is based on the 11-point NRS (0 [does not interfere] to 10 [completely interferes]).	Baseline, Week 8
Secondary	Patient Global Impression of Change (PGIC) Score at 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
Secondary	Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score	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