A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
- Summary
- Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
- Acronym
- PROGRESS
- Short title
- A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
- Official title
- A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-02-24
- First posted
- 2024-01-12
- Registry last updated
- 2025-10-10
- Primary completion date
- 2025-01-14
- Start date
- 2023-11-29
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Lexicon Pharmaceuticals
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06203002
- ClinicalTrials.gov ID
- NCT06203002
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
Timeframe: Baseline, Week 8
ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
Change from Baseline to Week 8 in Burning Pain
Timeframe: Baseline, Week 8
Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]).
Change from Baseline to Week 8 in Pain Interference on Sleep
Timeframe: Baseline, Week 8
Pain interference on sleep is based on the 11-point NRS (0 \[does not interfere\] to 10 \[completely interferes\]).
Patient Global Impression of Change (PGIC) Score at Week 8
Timeframe: 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.
Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Participant has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female participants ≥18 years of age at the Screening Visit
- Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening
- Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
- Pain from DPNP present for at least 6 months prior to Screening
- At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
- Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
- Willing to adhere to the prohibitions and restrictions specified in the protocol.
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
- Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
- Lexicon Investigational Site (128)Anniston, United States
- Lexicon Investigational Site (222)Birmingham, United States
- Lexicon Investigational Site (189)Daphne, United States
- Lexicon Investigational Site (215)Guntersville, United States
- Lexicon Investigational Site (115)Chandler, United States
- Lexicon Investigational Site (195)Phoenix, United States
- Lexicon Investigational Site (206)Scottsdale, United States
- Lexicon Investigational Site (102)Tucson, United States
- Lexicon Investigational Site (107)Anaheim, United States
- Lexicon Investigational Site (173)Canoga Park, United States
- Lexicon Investigational Site (179)Escondido, United States
- Lexicon Investigational Site (161)Fresno, United States
- Lexicon Investigational Site (112)Greenbrae, United States
- Lexicon Investigational Site (204)Huntington Beach, United States
- Lexicon Investigational Site (191)Inglewood, United States
- Lexicon Investigational Site (163)Lomita, United States
- Lexicon Investigational Site (169)Long Beach, United States
- Lexicon Investigational Site (111)Sacramento, United States
- Lexicon Investigational Site (126)Sacramento, United States
- Lexicon Investigational Site (129)San Diego, United States
- Lexicon Investigational Site (154)San Diego, United States
- Lexicon Investigational Site (124)Tustin, United States
- Lexicon Investigational Site (211)Vista, United States
- Lexicon Investigational Site (171)Walnut Creek, United States
- Lexicon Investigational Site (181)Walnut Creek, United States
And 83 more, listed on the interactive page.
Other registry identifiers
- LX9211.204-DPN