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

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this exploratory trial, the potential anti-seizure activity of clioquinol in a small cohort of adolescents with drug-resistant epilepsy will be examined. Subjects will be exposed to clioquinol add-on for a period of maximum 8 weeks (2 weeks low dose, 6 weeks higher dose). The main hypothesis of the study is that 30% of the included subjects will be responders and that the median seizure frequency reduction will be at least 30%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KU Leuven

Criteria

Inclusion Criteria:

Participants eligible for inclusion in this Trial must meet all of the following criteria:

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 ≥ 12 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)

Exclusion Criteria:

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 ethnicity

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