Administering Clioquinol to children with drug-resistant epilepsy
- Conditions
- Drug resistant epilepsy in childrenMedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-004511-27-BE
- Lead Sponsor
- niversity Hospital Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2.In females with child bearing potential: negative pregnancy test or use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some intra-uterine devices, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomized partner
3.Age = 4 years and < 18 years at time of inclusion
4.Weight = 20 kg at time of inclusion
5.Well defined epilepsy history with convulsive seizures (with observable and countable motor component)
6.Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs
7.Drug-resistant epilepsy: = 4 seizures in the 2 week prospective period (baseline) before visit 2, not all (4) seizures observed in 1 of the 2 weeks. Baseline period can be extended with 1 or 2 weeks.
8.The patient is at the moment of inclusion on max 3 anti-epileptic drugs (VNS and ketogenic diet not included)
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
1.Participant has a history of liver or kidney disease. Children with a co-existing active neuropathy (such as neuritis optica, transverse myelitis)
2.Asian etnicity
3. Abnormal low blood level of vitamin B12 or Zn
4.Patients with hypothyroidism
5.Any disorder, which in the Investigator’s opinion might jeopardize the participant’s safety or compliance with the protocol
6.Any prior or concomitant treatment(s) that might jeopardize the participant’s safety or that would compromise the integrity of the Trial
7.Exposure to clioquinol before the trial
8.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
9.Participation in an interventional Trial with an IMP or device
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study whether add-on clioquinol decreases the seizure frequency and severity in children with drug-resistant epilepsy.;Secondary Objective: a. Safety during trial (systematic recording of adverse events)<br>b. Assessment of seizure severity with the National Hospital Seizure Severity Scale (NHS3 scale)<br>c. Assessment of overall impact of seizures, medication<br>side effects, comorbidities, and overall Quality of Life (QoL) using the Personal Impact of Epilepsy Scale (PIES);Primary end point(s): Efficacy of Clioquinol will be measured:<br>a. percentage of 50% responders after 2 weeks and 10 weeks exposure to low (1mg/kg BID) and higher dose (4mg/kg BID) of clioquinol respectively (visit 3 and 5)<br>b. median % reduction of the seizure frequency at visit 5;Timepoint(s) of evaluation of this end point: A and B is evaluated on visit 3 and 5.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): (Cardiac) Safety, QoL and seizure severity;Timepoint(s) of evaluation of this end point: ECG: Screening and visit 5<br>AE + Concomitant medication: every visit<br>QoL and seizure severity: Visit 2, 3, 5 and 6<br>