NCT05593614Active, not recruitingPhase 2
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10% and 15% w/w) in Comparison to Placebo, in Cancer Survivor Adult Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- AlgoTherapeutix
- Enrollment
- 276
- Locations
- 43
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ATX01 10%
Experimental
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.
Intervention: ATX01 10% (Drug)
ATX01 15%
Experimental
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.
Intervention: ATX01 15% (Drug)
ATX01 Placebo
Placebo Comparator
A bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 12 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (43)
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