Project name:
Research clinical sites sought for ATX01 - Phase 2 study in Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Status: Idea
Creation date: 30-11-2022
Project objectives:
Short summary
The French company is developing a topical product to improve pain in patients suffering from Chemotherapy-Induced Peripheral Neuropathy (CIPN). In a Phase 1 study conducted in healthy volunteers, ATX01 showed very good local and systemic tolerance with very limited plasma exposure of the active substance. Therefore, the French company decided to conduct a worldwide double-blind, placebo controlled Phase 2 study. Research clinical sites are sought for this Phase 2 study.
Full description The use of high-dose amitriptyline has been the subject of some clinical investigations in the recent past and has tended to show that such a product improves pain in CIPN. The French company is currently conducting a multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of ATX01 (topical amitriptyline hydrochloride 10% and 15% w/w) compared to placebo, in cancer survivor adult patients with chemotherapy-induced peripheral neuropathy (CIPN). The study protocol has been approved by the FDA (USA) and the European authorities as well as the different ethics committees. Patients will be treated for 3 consecutive months by applying any of the topical products on the hands and/or feet. A certain number of exclusion and inclusion criteria have been set and can be provided in an attached document upon request. There are some pain and function/quality of life endpoints to be assessed at different time points. The study is being deployed in Europe and the USA at over 40 sites. The French company is looking for sites that are motivated to participate in such a research clinical trial on CIPN and have the potential to recruit the required patient population.
Technical Specification or Expertise Sought Research clinical sites are sought. They have to be: . motivated to participate in the proposed clinical trial on CIPN . able to recruit the required patient population.
Contact / source: NEXT EEN Widgets (europa.eu)
Full description The use of high-dose amitriptyline has been the subject of some clinical investigations in the recent past and has tended to show that such a product improves pain in CIPN. The French company is currently conducting a multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of ATX01 (topical amitriptyline hydrochloride 10% and 15% w/w) compared to placebo, in cancer survivor adult patients with chemotherapy-induced peripheral neuropathy (CIPN). The study protocol has been approved by the FDA (USA) and the European authorities as well as the different ethics committees. Patients will be treated for 3 consecutive months by applying any of the topical products on the hands and/or feet. A certain number of exclusion and inclusion criteria have been set and can be provided in an attached document upon request. There are some pain and function/quality of life endpoints to be assessed at different time points. The study is being deployed in Europe and the USA at over 40 sites. The French company is looking for sites that are motivated to participate in such a research clinical trial on CIPN and have the potential to recruit the required patient population.
Technical Specification or Expertise Sought Research clinical sites are sought. They have to be: . motivated to participate in the proposed clinical trial on CIPN . able to recruit the required patient population.
Contact / source: NEXT EEN Widgets (europa.eu)
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