A Phase 2a Trial to Explore the Efficacy and Safety of OXT-328 5% Topical Gel in Patients with Chemotherapy-Induced Peripheral Neuropathy, Diabetic Peripheral Neuropathy, and Cervical Radiculopathy

Condition studied

Peripheral neuropathy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in GS-NRS from pre-dose to 2 hours after the first Day 1 applications, pooled across cohorts

Endpoint detail

Two-hour GS-NRS responder rate (≥30% reduction from pre-dose [T0] to 2 hours after the first Day 1 applications), Proportion of participants with ‘very much improved’ or ‘much improved’ Patient Global Impression of Change (PGIC) scores at end of day (EOD) Day 3, Change in average daily GS-NRS scores on Days 1, 2 and 3, as well as the mean across Days 1–3, compared to the average Screening GS-NRS scores, Cohort-specific endpoints (i.e., disease-‍specific instruments): CIPN: Change from baseline in BPI-SF pain severity and interference scores at EOD Day 3, DPN: Change from baseline in NTSS-6 and BPI-DPN at EOD Day 3, CR: Change from baseline in region-‍specific arm/neck GS-NRS, NDI, BPI-SF, and PSFS, Incidence and severity of treatment-‍emergent adverse events (TEAEs), Local tolerability at the application site (stinging, burning, erythema, maceration, itch or discomfort) and dermatitis adverse events (AEs), Incidence of serious adverse events (SAEs), Treatment discontinuations due to AEs, Change in GS-NRS from pre-dose (T0) to 2 hours after the first Day 10 applications