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 â¥30% 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 â¥50% 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
ðºðžBellaire, Texas, United States
Neuroscience Research Center, LLC.
ðºðžOverland Park, Kansas, United States
University of Rochester Medical Center
ðºðžRochester, New York, United States
Gemelli Molise S.p.a.
ð®ð¹Campobasso, Italy
Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu Przewleklego
ðµð±Tychy, Poland
Universitair Ziekenhuis Antwerpen
ð§ðªEdegem, Belgium
OLV Hospital Aalst: gastro-enterologie
ð§ðªAalst, Belgium
Instytut "Centrum Zdrowia Matki Polki" Klinika Onkologii
ðµð±Åódź, Poland
South Lake Pain Institute
ðºðžClermont, Florida, United States
MGM Medical Care Research & Rehab, LLC
ðºðžMiami, Florida, United States
Medsol Clinical Research Center, Inc
ðºðžPort Charlotte, Florida, United States
Knight Neurology - Clinical Research
ðºðžRockledge, Florida, United States
The Center for Cancer and Blood Disorders (CCBD)
ðºðžBethesda, Maryland, United States
UZ Leuven / Campus Pellenberg / Pain Center
ð§ðªPellenberg, Belgium
Clinitrial s.r.o.
ðšð¿Prague, Czechia
Universitair Ziekenhuis Gent (UZ Gent)
ð§ðªGent, Belgium
CHU UCL Namur - site Godinne
ð§ðªYvoir, Belgium
Nemocnice Teplice
ðšð¿Teplice, Czechia
CHU de Montpellier, HÃŽpital Saint Eloi
ð«ð·Montpellier, France
Praglandia s.r.o.
ðšð¿Prague, Czechia
Centre Hospitalier de la CÃŽte Basque
ð«ð·Bayonne, France
Institute Bergonie
ð«ð·Bordeaux, France
Groupe Hospitalier Paris Saint Joseph
ð«ð·Paris, France
GODINOT Institute
ð«ð·Reims, France
CHU POITIERS, Hépato-Gastro Entérologie
ð«ð·Poitiers, France
Strasbourg Oncologie Liberale
ð«ð·Strasbourg, France
HÃŽpital Foch
ð«ð·Suresnes, France
Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST)
ð®ð¹Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale -. Maggiore Policlinico
ð®ð¹Milan, Italy
ASST Monza - Ospedale S. Gerardo di Monza
ð®ð¹Monza, Italy
Azienda Ospedaliera San Camillo-Forlanini
ð®ð¹Roma, Italy
Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di Pavia
ð®ð¹Pavia, Italy
Complejo Hospitalarion de Jaen
ðªðžJaén, Spain
Przychodnia Lekarska "Komed" Roman Karaszewski Oddzial Chemioterapii Jednego Dnia
ðµð±Konin, Poland
ClinHouse sp z o.o. - ClinHouse Centrum Medyczne
ðµð±Zabrze, Poland
Hospital de la Santa Creu I de Sant Pau
ðªðžBarcelona, Spain
Hospital Universitari de Bellvitge
ðªðžBarcelona, Spain
Hospital Universitario Reina Sofia
ðªðžCórdoba, Spain
Hospital Universitari Sant Joan de Reus
ðªðžReus, Spain
Madrid Sanchinarro Hospital
ðªðžMadrid, Spain
Unidad de Investigacion Clinica FINCIVO
ðªðžValencia, Spain
Hospital Ruber Internacional
ðªðžMadrid, Spain
Hospital General Universitario Gregorio Maranon
ðªðžMadrid, Spain