Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (NCT05593614)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: South Lake Pain Institute — Clermont, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- South Lake Pain Institute — Clermont, Florida
- MGM Medical Care Research & Rehab, LLC — Miami, Florida
- Medsol Clinical Research Center, Inc — Port Charlotte, Florida
- Knight Neurology - Clinical Research — Rockledge, Florida
- Neuroscience Research Center, LLC. — Overland Park, Kansas
- The Center for Cancer and Blood Disorders (CCBD) — Bethesda, Maryland
- University of Rochester Medical Center — Rochester, New York
- HD Research — Bellaire, Texas
- OLV Hospital Aalst: gastro-enterologie — Aalst,
- Universitair Ziekenhuis Antwerpen — Edegem,
- Universitair Ziekenhuis Gent (UZ Gent) — Ghent,
- UZ Leuven / Campus Pellenberg / Pain Center — Pellenberg,
- CHU UCL Namur - site Godinne — Yvoir,
- Clinitrial s.r.o. — Prague,
- Praglandia s.r.o. — Prague,
- Nemocnice Teplice — Teplice,
- Centre Hospitalier de la Côte Basque — Bayonne,
- Institute Bergonie — Bordeaux,
- CHU de Montpellier, Hôpital Saint Eloi — Montpellier,
- Groupe Hospitalier Paris Saint Joseph — Paris,
- CHU POITIERS, Hépato-Gastro Entérologie — Poitiers,
- GODINOT Institute — Reims,
- Strasbourg Oncologie Liberale — Strasbourg,
- Hôpital Foch — Suresnes,
- Gemelli Molise S.p.a. — Campobasso,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chemotherapy-induced Peripheral Neuropathy
- The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy) — Boston, Massachusetts
- NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy — Iowa City, Iowa
- Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN) — Toronto, Ontario
- Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy — Houston, Texas
- PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy — Middletown, Connecticut
Explore by condition: All Chemotherapy-induced Peripheral Neuropathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.