Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Interventions
- Drug: ATX01 15%Drug: ATX01 10%Drug: Placebo
- Registration Number
- NCT05593614
- Lead Sponsor
- AlgoTherapeutix
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 276
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATX01 15% ATX01 15% A bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months. ATX01 10% ATX01 10% A bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months. ATX01 Placebo Placebo A bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.
- Primary Outcome Measures
Name Time Method 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. 12 weeks
- Secondary Outcome Measures
Name Time Method Proportion of patients achieving various percentages of reduction in worst pain intensity in target study extremities (cumulative responder curve) throughout the study. 4 weeks, 8 weeks, 12 weeks Percentage of patients achieving โฅ30% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12 12 weeks Mean change from baseline to each visit in tingling/pins and needles intensity and numbness intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom 4 weeks, 8 weeks, 12 weeks Proportion of patients achieving various percentages of reduction in average pain intensity in target study extremities (cumulative responder curve) throughout the study. 4 weeks, 8 weeks, 12 weeks Percentage of patients with at least "improved" on the Patient Global Impression of Change (PGI-C) at each visit 4 weeks, 8 weeks, 12 weeks Mean change from baseline to each visit in pain interference with daily life using the Brief Pain Inventory Short Form questionnaire (BPI-SF item 9 only) 4 weeks, 8 weeks, 12 weeks Percentage of patients achieving โฅ50% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12. 12 weeks Change from baseline to Week 4 and 8 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 4 weeks, 8 weeks Change from baseline to each visit in the weekly mean of the daily NPRS assessing worst pain intensity in target study extremities related to CIPN in the past 24 hours 4 weeks, 8 weeks, 12 weeks Mean change from baseline to each visit in the calculated mean NPRS average pain intensity in the nontarget study extremities 4 weeks, 8 weeks, 12 weeks Mean change from baseline to Week 12 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN 20-item scale (EORTC QLQ CIPN20) 12 weeks Use of rescue medication including the proportion of patients using rescue medication, the frequency, and amount used Up to 12 weeks
Trial Locations
- Locations (43)
HD Research
๐บ๐ธBellaire, Texas, United States
Neuroscience Research Center, LLC.
๐บ๐ธOverland Park, Kansas, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Gemelli Molise S.p.a.
๐ฎ๐นCampobasso, Italy
Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu Przewleklego
๐ต๐ฑTychy, Poland
Universitair Ziekenhuis Antwerpen
๐ง๐ชEdegem, Belgium
OLV Hospital Aalst: gastro-enterologie
๐ง๐ชAalst, Belgium
Instytut "Centrum Zdrowia Matki Polki" Klinika Onkologii
๐ต๐ฑลรณdลบ, Poland
South Lake Pain Institute
๐บ๐ธClermont, Florida, United States
MGM Medical Care Research & Rehab, LLC
๐บ๐ธMiami, Florida, United States
Medsol Clinical Research Center, Inc
๐บ๐ธPort Charlotte, Florida, United States
Knight Neurology - Clinical Research
๐บ๐ธRockledge, Florida, United States
The Center for Cancer and Blood Disorders (CCBD)
๐บ๐ธBethesda, Maryland, United States
UZ Leuven / Campus Pellenberg / Pain Center
๐ง๐ชPellenberg, Belgium
Clinitrial s.r.o.
๐จ๐ฟPrague, Czechia
Universitair Ziekenhuis Gent (UZ Gent)
๐ง๐ชGent, Belgium
CHU UCL Namur - site Godinne
๐ง๐ชYvoir, Belgium
Nemocnice Teplice
๐จ๐ฟTeplice, Czechia
CHU de Montpellier, Hรดpital Saint Eloi
๐ซ๐ทMontpellier, France
Praglandia s.r.o.
๐จ๐ฟPrague, Czechia
Centre Hospitalier de la Cรดte Basque
๐ซ๐ทBayonne, France
Institute Bergonie
๐ซ๐ทBordeaux, France
Groupe Hospitalier Paris Saint Joseph
๐ซ๐ทParis, France
GODINOT Institute
๐ซ๐ทReims, France
CHU POITIERS, Hรฉpato-Gastro Entรฉrologie
๐ซ๐ทPoitiers, France
Strasbourg Oncologie Liberale
๐ซ๐ทStrasbourg, France
Hรดpital Foch
๐ซ๐ทSuresnes, France
Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST)
๐ฎ๐นMeldola, Italy
Fondazione IRCCS Ca' Granda Ospedale -. Maggiore Policlinico
๐ฎ๐นMilan, Italy
ASST Monza - Ospedale S. Gerardo di Monza
๐ฎ๐นMonza, Italy
Azienda Ospedaliera San Camillo-Forlanini
๐ฎ๐นRoma, Italy
Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di Pavia
๐ฎ๐นPavia, Italy
Complejo Hospitalarion de Jaen
๐ช๐ธJaรฉn, Spain
Przychodnia Lekarska "Komed" Roman Karaszewski Oddzial Chemioterapii Jednego Dnia
๐ต๐ฑKonin, Poland
ClinHouse sp z o.o. - ClinHouse Centrum Medyczne
๐ต๐ฑZabrze, Poland
Hospital de la Santa Creu I de Sant Pau
๐ช๐ธBarcelona, Spain
Hospital Universitari de Bellvitge
๐ช๐ธBarcelona, Spain
Hospital Universitario Reina Sofia
๐ช๐ธCรณrdoba, Spain
Hospital Universitari Sant Joan de Reus
๐ช๐ธReus, Spain
Madrid Sanchinarro Hospital
๐ช๐ธMadrid, Spain
Unidad de Investigacion Clinica FINCIVO
๐ช๐ธValencia, Spain
Hospital Ruber Internacional
๐ช๐ธMadrid, Spain
Hospital General Universitario Gregorio Maranon
๐ช๐ธMadrid, Spain