A Phase 2 interventional study of Placebo (blinded) and LX9211 (blinded) in Diabetic Peripheral Neuropathic Pain, sponsored by Lexicon Pharmaceuticals. Completed at 108 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Lexicon Pharmaceuticals · Phase 2, Interventional, and Treatment
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
Exclusion Criteria:
LX9211 low dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 high dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 matching placebo, orally, once daily during a blinded treatment period.
Drug: Placebo (blinded)
LX9211 matching placebo tablets
LX9211 (blinded) tablets
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
Time frame: Baseline, Week 8
Change from Baseline to Week 8 in Burning Pain
Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]).
Time frame: Baseline, Week 8
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 \[completely interferes\]).
Time frame: Baseline, Week 8
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.
Time frame: Week 8
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.
Time frame: Baseline, Week 8
Showing the first 100 of 108 sites.
Plan to share: No
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Lexicon Pharmaceuticals