NCT05593614

Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10% and 15% w/w) in Comparison to Placebo, in Cancer Survivor Adult Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: AlgoTherapeutix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% \& 15%) versus placebo during a 12-week treatment period in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	ATX01 10%	A 100 mL bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w
DRUG	ATX01 15%	A 100 mL bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w
DRUG	Placebo	A 100 mL bottle of hydrogel formulation containing no active substance

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-10-25
• Last updated: 2024-07-16

Locations

43 sites across 7 countries: United States, Belgium, Czechia, France, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study