Add-on Clioquinol in drug-resistant epilepsy: an exploratory study

Phase 1

Recruiting

• Conditions: Drug resistant epilepsy; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-511388-27-04
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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., Age = 12 years and < 35 years at time of inclusion, Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs, The patient is at the moment of inclusion on max 3 anti-epileptic drugs (VNS and ketogenic diet not included), Well defined epilepsy history with convulsive seizures (with observable and countable motor component)

Exclusion Criteria

Presence of C609T NQO1 SNP after SNP analysis of NQO1 based on a blood sample during baseline visit (visit 1) by Genomics Core, Asian etnicity, Abnormal low blood level of vitamin B12 or Zn

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 patients with drug-resistant epilepsy.;Secondary Objective: Safety during trial (systematic recording of adverse events), Assessment of seizure severity with the National Hospital Seizure Severity Scale (NHS3 scale), Assessment of overall impact of seizures, medication side effects, comorbidities, and overall Quality of Life (QoL) using the Personal Impact of Epilepsy Scale (PIES);Primary end point(s): Percentage of 50% responders after 2 weeks and 6 weeks exposure to low and higher doses of clioquinol respectively (visit 3 and visit 5), Median % reduction of the seizure frequency at visit 5

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Safety during trial (systematic recording of adverse events) Clinical neurological examination during the trial will identify children with possible neuropathy Adverse events will be reported (clinical and biochemical).;Secondary end point(s):Assessment of seizure severity (NHS3 scale);Secondary end point(s):Assessment of overall impact of seizures, medication side effects, comorbidities, and overall QoL (PIES).