Open label extension study for monitoring long-term safety in patients with Myoclonic Astatic Epilepsy (Doose-Syndrome) receiving Fenfluramine as add-on therapy
Key facts
- Where
- Bielefeld, Kiel és Vogtareuth, NémetországSee the 3 sites
- Phase
- 2. fázis
Where in Németország
- Krankenhaus Mara gGmbHBielefeld, NémetországNo longer taking part
- Universitaetsklinikum Schleswig-Holstein AöRKiel, NémetországNo longer taking part
- Schoen Klinik Vogtareuth SE & Co. KGVogtareuth, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Schleswig-Holstein AöR
- Trial code
- EU 2024-518520-77-00
- Record updated
- 2026. április 14.
- Original description
The aim of this study is to monitor the individual long-term safety and efficacy of low dose Fenfluramine (minimum 0.2 mg/kg/day BID up to a maximum of 0.8 mg/kg/day BID, max 30.0 mg/day) as add-on therapy. At the discretion of the investigator, an individual, if necessary repeated, gradual adaptation of the dose to the respective situation of the seizures is possible in this extension study.Read full original descriptionShow less
The aim of this study is to monitor the individual long-term safety and efficacy of low dose Fenfluramine (minimum 0.2 mg/kg/day BID up to a maximum of 0.8 mg/kg/day BID, max 30.0 mg/day) as add-on therapy. At the discretion of the investigator, an individual, if necessary repeated, gradual adaptation of the dose to the respective situation of the seizures is possible in this extension study.
Inclusion: Subjects is currently enrolled in FFA-MAE-study; Subject and parents/caregiver have been informed of the nature of the study and written informed consent has been obtained from the patient and the legally responsible parents/caregiver; Subject is between 1 (12 months) and 17 years; In the medical opinion of the Investigator, subject must be a candidate for continued treatment for an extended period of time with Fenfluramine (i.e. subject has demonstrated a clinically meaningful benefit with Fenfluramine in the prior trial (FFA-MAE), and benefits of continued treatment outweigh potential risks); Clinically meaningful benefit is defined as follows: at least 50% reduction of total number of seizures (sum of GTKA, TS, AS, AB, MS) compared to baseline in FFA-MAE-study; Subjects receives >= 1 AED in addition to Fenfluramine.
Exclusion: Certain drugs, as listed in the prohibited food & medication section in the protocol; Subject has a known hypersensitivity to Fenfluramine hydrochloride or other components in the study formulation; Weight loss of 10 percent or more compared to visit 2 (first intake of IMP) of the FFA-MAE study; Intake of any investigational medicinal product (IMP) other than Fenfluramine; Any cardiovascular abnormality.