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

NCT05593614 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2024-07-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • AlgoTherapeutix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05593614 on ClinicalTrials.gov