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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02655198
Other study ID # S58545
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 2016
Est. completion date December 2024

Study information

Verified date September 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline and at the end of the study, ECG and ultrasound of the heart will be performed as part of the safety follow up.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13
Est. completion date December 2024
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fenfluramine
study of efficacy and safety of add-on fenfluramine at different dosages in refractory Lennox Gastaut patients : 0.2 - 0.4 and 0.8 mg/kg/day (max 30 mg).

Locations

Country Name City State
Belgium University Hospitals UZ Leuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
KU Leuven Zogenix, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) up to 20 weeks
Secondary Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS)) 20 weeks
Secondary Adverse events (cardiac and general) 20 weeks
Secondary Sleep quality : 10 point scale instrument to score sleep quality 20 weeks
Secondary CGI (clinical global impression) scale at last visit , by patient/caregiver and treating physician 20 weeks
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