2024-518520-77-00Active, not recruitingPhase 2
Open label extension study for monitoring long-term safety in patients with Myoclonic Astatic Epilepsy (Doose-Syndrome) receiving Fenfluramine as add-on therapy
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 24 Nov 2021
- Lead sponsor
- Universitaetsklinikum Schleswig-Holstein AöR
- Diseases
- Epilepsy
- EU CT number
- 2024-518520-77-00
- EudraCT number
- 2020-002238-34
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Certain drugs, as listed in the prohibited food & medication section in the protocol
Other illness
- Subject has a known hypersensitivity to Fenfluramine hydrochloride or other components in the study formulation
Other
- 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
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Krankenhaus Mara gGmbH | Bielefeld | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR | Kiel | Germany | Active, not recruiting |
| Schoen Klinik Vogtareuth SE & Co. KG | Vogtareuth | Germany | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.