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Topical Analgesic
ATX01 for Chemotherapy-Induced Nerve Pain (ACT Trial)
Phase 2
Recruiting
Research Sponsored by AlgoTherapeutix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks, 8 weeks, 12 weeks
Awards & highlights
ACT Trial Summary
This trial tests if ATX01 can help relieve chemotherapy-induced nerve pain in cancer survivors.
Who is the study for?
Adults over 18 with painful sensory CIPN from cancer treatment, who've stopped chemotherapy for at least 24 weeks. They must have a BMI of 18-35 kg/m2, life expectancy over 6 months, and pain intensity between 4 and 9 on the NPRS scale. Exclusions include glaucoma, recent heart issues, major depression or psychiatric disorders, pregnancy or lactation, certain ECG abnormalities, use of specific medications including opioids and MAO inhibitors within set timeframes before the trial.Check my eligibility
What is being tested?
The trial tests ATX01 cream (10% &15%) against placebo in treating CIPN when applied twice daily for a period of twelve weeks. The goal is to see if ATX01 can reduce neuropathy pain better than a non-active cream.See study design
What are the potential side effects?
While not specified here, topical treatments like ATX01 could cause skin irritation or allergic reactions at the site of application. Systemic side effects are less common but may include dizziness or nausea.
ACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks, 8 weeks, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks, 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Limb structure
Secondary outcome measures
Limb structure
Limb structure
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)
+9 moreACT Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ATX01 15%Experimental Treatment1 Intervention
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.
Group II: ATX01 10%Experimental Treatment1 Intervention
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.
Group III: ATX01 PlaceboPlacebo Group1 Intervention
A bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral neuropathy treatments, particularly topical applications like those in the ATX01 trial, work by targeting local pain receptors and reducing inflammation. Agents such as amitriptyline, ketamine, and menthol modulate pain pathways by blocking sodium channels, NMDA receptors, and activating TRPM8 receptors, respectively.
This localized approach is important for patients as it can provide effective pain relief with fewer systemic side effects compared to oral medications.
[Peripheral neuropathy rehabilitation. Indications for a diagnostic-rehabilitation approach].
[Peripheral neuropathy rehabilitation. Indications for a diagnostic-rehabilitation approach].
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Who is running the clinical trial?
AlgoTherapeutixLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My body processes some medications slowly.I have glaucoma.I have had chest pain or a heart attack in the last year.I haven't changed my neuropathy treatment, except for AMT, in the last 4 weeks.I am not expected to need treatments that could interfere with the study.I am 18 years old or older.I stopped my chemotherapy with taxanes, platins, or any neurotoxic drugs over 24 weeks ago.I have not taken AMT or nortriptyline in the last 4 weeks.I haven't used any medical creams on my arms or legs except for cosmetic reasons in the last 3 months.I haven't used any skin creams or pain relievers on my limbs for pain in the specified time before my first visit.I have had nerve pain from chemotherapy for 6 months or more.I have similar pain in both my hands and feet.I have significant nerve pain in my hands or feet.I haven't taken any monoamine oxidase inhibitors in the last 24 weeks.I cannot take acetaminophen/paracetamol due to health reasons.I have trouble emptying my bladder completely or have a significantly enlarged prostate.I haven't taken strong CYP2D6 inhibitors in the last 4 weeks.I agree to use two forms of birth control if I'm sexually active with a woman who can have children, and not to donate sperm until 30 days after my last dose.My pain level in my hands or feet is between 4 and 9 on a scale of 0 to 10.My CIPN pain didn't improve after trying more than 2 different pain relief medications.I do not have skin irritation or wounds on my hands or feet.I haven't taken glutathione, vitamin E, or minocycline in the last 12 weeks.I am a woman not pregnant, using birth control, or cannot have children.I have nerve pain not caused by chemotherapy, like from diabetes or an injury.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).I haven't taken any medications in the last 24 weeks that affect my heart's rhythm.I haven't used opioids in the last 4 weeks or during the study.I have nerve pain in my hands or feet from cancer treatment with taxanes or platins.
Research Study Groups:
This trial has the following groups:- Group 1: ATX01 Placebo
- Group 2: ATX01 10%
- Group 3: ATX01 15%
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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