Cessatech A/S has announced that its Paediatric Study 0202, evaluating CT001 for acute pain in children, has reached a significant milestone with 75 patients now recruited. This marks the halfway point in the trial, which is the final clinical study required to assess the safety and efficacy of CT001 in a cohort of 150 children. The study is currently being conducted at various sites in Spain and the UK, with recruitment expected to conclude by the end of 2024.
CT001 is a nasal spray designed for the treatment of acute and procedural pain in children. Its development is being carried out in accordance with a paediatric investigation plan (PIP) endorsed by the EMA's Paediatric Committee, reflecting a commitment to meeting the specific needs of young patients.
Management Perspective
Jes Trygved, CEO of Cessatech, expressed satisfaction with the progress of the study: "We are very pleased with this halfway milestone in our final study for the development of CT001 in paediatric patients. We had a slow start during the summer holiday period, but since beginning of September all sites are up and running and we have recruited more than 30 patients, this is a fantastic achievement and great effort by the team – and a potentially good indication that the product is well accepted among the involved sites. CT001 is now one step closer to finalize the clinical program and becoming available to hospitals and the children that really need approved, easy to administer pain relief."
About CT001
CT001 offers a needle-free, easily administered option for pain relief, designed to provide a fast-acting therapeutic effect. Cessatech is dedicated to developing and commercializing evidence-based medicines for children's acute pain management. CT001 is currently in its pivotal stage of clinical development.
