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ATX01 for Chemotherapy-Induced Nerve Pain (ACT Trial)
ACT Trial Summary
This trial tests if ATX01 can help relieve chemotherapy-induced nerve pain in cancer survivors.
ACT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ACT Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: ATX01 10%
- Group 2: ATX01 15%
- Group 3: ATX01 Placebo
- 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.
Frequently Asked Questions
Has ATX01 achieved regulatory authorization at the level of 10%?
"ATX01 10% was awarded a safety score of 2 on our internal scale due to the lack clinical data in Phase 2 trials that supports its efficacy."
Are individuals still being accepted to participate in this research?
"Affirmative. Clinicaltrials.gov states that this medical trial is currently accepting participants, with a first post date of January 1st 2023 and most recent update happening on 23rd Jan 2023. The study aims to enrol 240 people at 2 separate locations"
What is the current enrollment capacity of this clinical research trial?
"Affirmative, the clinical trial is currently seeking participants. Initially advertised on January 1st 2023 and most recently updated on January 23rd 2023, this study requires 240 enrollees from two separate locations."
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