Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT02655198
• Date of registration: 12/01/2016
• Prospective Registration: No
• Primary sponsor: KU Leuven
• Public title: Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy FFA-LGS
• Scientific title: Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy
• Date of first enrolment: January 2016
• Target sample size: 13
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02655198
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Lieven G Lagae, MD, PhD
• Affiliation: Katolieke Universiteit Leuven, University Hospitals Gasthuisberg

Key inclusion & exclusion 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

- Subject is male or non-pregnant, non-lactating female. Female subjects of childbearing
potential must not be pregnant or breast-feeding. Female subjects of childbearing
potential must have a negative urine pregnancy test. Subjects of childbearing or
child-fathering potential must be willing to use medically acceptable forms of birth
control, which includes abstinence, while being treated on this study and for 90 days
after the last dose of study drug.

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

- Subject is receiving concomitant therapy with: centrally-acting anorectic agents;
monoamine oxidase inhibitors; any centrally-acting compound with clinically
appreciable amount of serotonin agonist or antagonist properties, including serotonin
reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist;
cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.

- Subject is unwilling to refrain from large or daily servings of grapefruits and/or
Seville oranges, and their juices beginning with the Baseline Period and throughout
the study.



Age minimum: 3 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Lennox Gastaut Syndrome

Intervention(s)

Drug: Fenfluramine

Primary Outcome(s)

Efficacy of add-on FFA in Lennox Gastaut epilepsy: Number of responders and seizure free patients at each FFA dosage (0,2 or 0,4 or 0,8 mg/kg/day) [Time Frame: up to 20 weeks]

Secondary Outcome(s)

Adverse events (cardiac and general) [Time Frame: 20 weeks]

Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS)) [Time Frame: 20 weeks]

Sleep quality : 10 point scale instrument to score sleep quality [Time Frame: 20 weeks]

CGI (clinical global impression) scale at last visit , by patient/caregiver and treating physician [Time Frame: 20 weeks]

Secondary ID(s)

S58545

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Zogenix, Inc.