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Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) - Trial NCT05593614

Access comprehensive clinical trial information for NCT05593614 through Pure Global AI's free database. This Phase 2 trial is sponsored by AlgoTherapeutix and is currently Recruiting. The study focuses on Chemotherapy-induced Peripheral Neuropathy. Target enrollment is 240 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05593614
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT05593614
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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)

Study Focus

ATX01 10%

Interventional

drug

Sponsor & Location

AlgoTherapeutix

Clermont,Bethesda,Prague,Paris,Suresnes,Konin,Tychy,Barcelona,Madrid,Terrassa, Czech,France,Poland,Spain,United States of America

Timeline & Enrollment

Phase 2

Jan 01, 2023

Dec 31, 2023

240 participants

Primary Outcome

Change from baseline to Week 12 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.

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.

ICD-10 Classifications

Drug-induced polyneuropathy
Paraneoplastic neuromyopathy and neuropathy
Polyneuropathy due to other toxic agents
Idiopathic peripheral autonomic neuropathy
Idiopathic progressive neuropathy

Data Source

ClinicalTrials.gov

NCT05593614

Non-Device Trial