An Investigation to see if the investigational product ZX008 (fenfluramine hydrochloride) contributes to reducing the incidence of seizures in children and young adults with Doose syndrome, an early childhood form of epilepsy.

Phase 1

• Conditions: Childhood epilepsy: Myoclonic Astatic Epilepsy (Doose-Syndrome); MedDRA version: 20.1Level: LLTClassification code 10015040Term: Epilepsy equivalentSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-001664-38-DE
• Lead Sponsor: niversity Hospital Schleswig-Holstein (UKSH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosis of Doose syndrome
• Age: 1 to 17 years.
• Normal cognitive development before the onset of epilepsy and absence of organic cerebral abnormalities.
• Onset of myoclonic, myoclonic-(atonic) astatic or atonic-astatic seizures, absences, status of „petit mal, generalized tonic clonic seizures; sometimes febrile seizures occur before the start of epilepsy.
• Multiple seizure types (at least 2) including in any case myoclonic atonic seizures
• at least 6 documented seizures in the last 4 weeks before inclusion
• on >= 1AED during the 4 weeks before inclusion
• Presence on EEG of biparietal theta background rhythm, and irregularly generalized spike wave, and polyspike wave
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any cardiovascular abnormality
• Abnormal weight (below age specific 3rd percentile)
• Cortical structural brain lesions.
• Presence of severe and benign myoclonic epilepsy (SME, BME) in infancy and early childhood
• Presence of cryptogenic Lennox-Gastaut syndrome, based on the ILAE definitions
• Presence of atypical benign partial epilepsy/pseudo-Lennox-syndrome
• Presence of other symptomatic / cryptogenic epilepsies (e.g. with a frontal lobe semiology).
• Progressive neurodegenerative disease
• certain drugs
• Glaucoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified