Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study

Korábbi kezelés

• Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial

Más betegség

• Participant has a history of liver or kidney disease. Children with a co-existing active neuropathy (such as neuritis optica, transverse myelitis)
• Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol

Egyéb

• Asian ethnicity
• Abnormal low blood level of vitamin B12 or Zn
• Patients with hypothyroidism
• Exposure to clioquinol before the trial
• 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
• Participation in an interventional Trial with an IMP or device

• Participants eligible for inclusion in this Trial must meet all of the following criteria:
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• 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
• Age ≥ 12 years and < 18 years at time of inclusion
• Weight ≥ 20 kg at time of inclusion
• Well defined epilepsy history with convulsive seizures (with observable and countable motor component)
• Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs
• 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.
• The patient is at the moment of inclusion on max 3 anti-epileptic drugs (VNS and ketogenic diet not included)