Add-on fenfluramine in Lennox Gastaut epilepsy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004008-46-BE

Enrollment

Unknown

Registered

2015-11-26

Start date

2016-01-07

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lennox Gastaut Epilepsy

Interventions

Product Name: fenfluramine Product Code: ZX-008 Pharmaceutical Form: Oral solution INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE CAS Number: 404-82-0 Other descriptive name: ZX008 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Electro-clinical epilepsy syndrome compatible with Lennox Gastaut syndrome Minimum requirements (based on ILAE epilepsydiagnosis.org) - multiple seizure types including in any case tonic seizures - EEG shows slow spike waves and abnormal background - abnormal cognitive development - MRI compatible with Lennox Gastaut epilepsy : no progressive disease - Drug resistant : - at least 4 documented seizures in the last 4 weeks before inclusion (minimum 4 seizures in at least 2 separate weeks) Seizure types eligible for inclusion are : generalized tonic-clonic seizures GTC , tonic seizures TS , atonic seizures AS or clearly recognizable focal seizures FS. - on >= 2 AEDs (including VNS) during the 4 weeks before inclusion (no changes in treatment before inclusion and during the trial) - Age between 3 and 18 years Are the trial subjects under 18? yes Number of subjects for this age range: 20 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

Exclusion criteria: - Known clinical cardiovascular abnormalities (including valvular problems, shunts, pulmonary hypertension, exercise intolerance) - Any cardiac ultrasound/ECG abnormalities at baseline - Weight below percentile 3 for age at baseline

Design outcomes

Primary

Measure	Time frame
Main Objective: to study the potential effect of add-on fenfluramine in refractory Lennox Gastaut epilepsy. ( exploratory dose finding add-on trial). Primary outcome: Number of responders and seizure free patients (for all 4 major seizure types counted together) after each period (week 8, 12 and 16 and 20) and at each dosage (0,2 or 0,4 or 0,8 mg/kg/day);Secondary Objective: Secondary: Seizure frequency change per patient and per major seizure type (TCS, TS, AS, FS) Adverse events Sleep quality (scale to be discussed) CGI (clinical global impression) at last visit , by patient/caregiver and treating physician ;Primary end point(s): Number of responders and seizure free patients (for all 4 major seizure types counted together) after each period (week 8, 12 and 16 and 20) and at each dosage (0,2 or 0,4 or 0,8 mg/kg/day);Timepoint(s) of evaluation of this end point: 8, 12, 16 and 20 weeks after inclusion	—

Measure

Time frame

Main Objective: to study the potential effect of add-on fenfluramine in refractory Lennox Gastaut epilepsy. ( exploratory dose finding add-on trial). Primary outcome: Number of responders and seizure free patients (for all 4 major seizure types counted together) after each period (week 8, 12 and 16 and 20) and at each dosage (0,2 or 0,4 or 0,8 mg/kg/day);Secondary Objective: Secondary: Seizure frequency change per patient and per major seizure type (TCS, TS, AS, FS) Adverse events Sleep quality (scale to be discussed) CGI (clinical global impression) at last visit , by patient/caregiver and treating physician ;Primary end point(s): Number of responders and seizure free patients (for all 4 major seizure types counted together) after each period (week 8, 12 and 16 and 20) and at each dosage (0,2 or 0,4 or 0,8 mg/kg/day);Timepoint(s) of evaluation of this end point: 8, 12, 16 and 20 weeks after inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary: Seizure frequency change per patient and per major seizure type (TCS, TS, AS, FS) Adverse events Sleep quality (scale to be discussed) CGI (clinical global impression) at last visit , by patient/caregiver and treating physician ;Timepoint(s) of evaluation of this end point: 8, 12, 16 and 20 weeks after inclusion	—

Countries

Belgium

Contacts

Public ContactLieven Lagae

UZ Leuven

lieven.lagae@uzleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026