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 ≥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 ≥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)
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
MGM Medical Care Research & Rehab, LLC
🇺🇸Miami, Florida, United States
Medsol Clinical Research Center, Inc
🇺🇸Port Charlotte, Florida, United States
Knight Neurology - Clinical Research
🇺🇸Rockledge, Florida, United States
Neuroscience Research Center, LLC.
🇺🇸Overland Park, Kansas, United States
The Center for Cancer and Blood Disorders (CCBD)
🇺🇸Bethesda, Maryland, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
HD Research
🇺🇸Bellaire, Texas, United States
OLV Hospital Aalst: gastro-enterologie
🇧🇪Aalst, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Scroll for more (33 remaining)South Lake Pain Institute🇺🇸Clermont, Florida, United States