This clinical trial is focused on studying the long-term safety of a medication called Fenfluramine in patients with a type of epilepsy known as Myoclonic Astatic Epilepsy, also referred to as Doose Syndrome. The medication being tested is called Fintepla 2.2 mg/ml oral solution, which is taken by mouth. The purpose of the study is to monitor how safe and effective low doses of Fenfluramine are when used alongside other treatments for this condition.
Participants in the study will receive Fenfluramine as an additional therapy to their current treatment plan. The study will observe the effects of Fenfluramine over a long period, with doses ranging from 0.4 to 0.8 mg per kilogram of body weight per day, up to a maximum of 30 mg per day. The study aims to see if Fenfluramine can help reduce the number of seizures experienced by patients while ensuring that it remains safe for long-term use.
Throughout the study, various health checks will be conducted to ensure the safety of the participants. These checks include monitoring for any serious side effects, conducting laboratory tests, checking vital signs, and performing physical examinations. Additionally, heart health will be assessed using tests like the 12-lead electrocardiogram (ECG) and Doppler echocardiogram (ECHO). The study will also track changes in body weight to ensure the overall well-being of the participants.
Germany 
