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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

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

Trial Locations (43)

2650

Universitair Ziekenhuis Antwerpen, Edegem

3212

UZ Leuven / Campus Pellenberg / Pain Center, Pellenberg

5530

CHU UCL Namur - site Godinne, Yvoir

9000

Universitair Ziekenhuis Gent (UZ Gent), Ghent

9300

OLV Hospital Aalst: gastro-enterologie, Aalst

10000

Clinitrial s.r.o., Prague

14004

Hospital Universitario Reina Sofia, Córdoba

14642

University of Rochester Medical Center, Rochester

15000

Praglandia s.r.o., Prague

20122

Fondazione IRCCS Ca' Granda Ospedale -. Maggiore Policlinico, Milan

20817

The Center for Cancer and Blood Disorders (CCBD), Bethesda

20900

ASST Monza - Ospedale S. Gerardo di Monza, Monza

23007

Complejo Hospitalarion de Jaen, Jaén

27100

Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di Pavia, Pavia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Ruber Internacional, Madrid

28050

Madrid Sanchinarro Hospital, Madrid

32955

Knight Neurology - Clinical Research, Rockledge

33076

Institute Bergonie, Bordeaux

33173

MGM Medical Care Research & Rehab, LLC, Miami

33952

Medsol Clinical Research Center, Inc, Port Charlotte

34295

CHU de Montpellier, Hôpital Saint Eloi, Montpellier

34711

South Lake Pain Institute, Clermont

41529

Nemocnice Teplice, Teplice

41807

ClinHouse sp z o.o. - ClinHouse Centrum Medyczne, Zabrze

43100

Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu Przewleklego, Tychy

43204

Hospital Universitari Sant Joan de Reus, Reus

46009

Unidad de Investigacion Clinica FINCIVO, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST), Meldola

51100

GODINOT Institute, Reims

62500

"Przychodnia Lekarska Komed Roman Karaszewski Oddzial Chemioterapii Jednego Dnia", Konin

64100

Centre Hospitalier de la Côte Basque, Bayonne

66210

Neuroscience Research Center, LLC., Overland Park

67000

Strasbourg Oncologie Liberale, Strasbourg

75014

Groupe Hospitalier Paris Saint Joseph, Paris

77401

HD Research, Bellaire

86021

CHU POITIERS, Hépato-Gastro Entérologie, Poitiers

86100

Gemelli Molise S.p.a., Campobasso

92150

Hôpital Foch, Suresnes

93338

"Instytut Centrum Zdrowia Matki Polki Klinika Onkologii", Lodz

00152

Azienda Ospedaliera San Camillo-Forlanini, Roma

08041

Hospital de la Santa Creu I de Sant Pau, Barcelona

08907

Hospital Universitari de Bellvitge, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AlgoTherapeutix

INDUSTRY

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