Clinical trial • Phase IV • Musculoskeletal | Neurology

CLIOQUINOL for Drug-resistant epilepsy

Phase IV trial of CLIOQUINOL for Drug-resistant epilepsy. open-label. 20 participants.

Overview

open-label Phase IV trial in Belgium.

Recruits 20 paediatric patients.

Vulnerable Population: Includes minors aged 12-17 (age inclusion: ≥ 12 and < 35). Subject information and informed consent forms for 12-17-year-olds and for parents are listed among trial documents (L1_SIS and ICF 12-17yr; L1_SIS and ICF parents). isVulnerablePopulationSelected is false in the record.

{"criterion_text":"- 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.\n- Age ≥ 12 years and < 35 years at time of inclusion\n- Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs\n- The patient is at the moment of inclusion on max 4 anti-epileptic drugs (VNS and ketogenic diet not included)\n- Well defined epilepsy history with convulsive seizures (with observable and countable motor component)"}

{"criterion_text":"- Presence of C609T NQO1 SNP after SNP analysis of NQO1 based on a blood sample during baseline visit (visit 1) by Genomics Core\n- Asian etnicity\n- Abnormal low blood level of vitamin B12 or Zn"}

{"endpoint_text":"- Percentage of 50% responders after 2 weeks and 6 weeks exposure to low and higher doses of clioquinol respectively (visit 3 and visit 5)","definition_or_measurement_approach":"Percentage of participants achieving ≥ 50% reduction in seizure frequency measured after 2 weeks (low dose, visit 3) and after 6 weeks (higher dose, visit 5)."}
{"endpoint_text":"- Median % reduction of the seizure frequency at visit 5","definition_or_measurement_approach":"Median percent reduction in seizure frequency measured at visit 5 (after higher dose exposure)."}

{"endpoint_text":"- 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).","definition_or_measurement_approach":"Systematic recording of adverse events (clinical and biochemical); clinical neurological examinations to identify possible neuropathy."}
{"endpoint_text":"- Assessment of seizure severity (NHS3 scale)","definition_or_measurement_approach":"Seizure severity assessed using the National Hospital Seizure Severity Scale (NHS3)."}
{"endpoint_text":"- Assessment of overall impact of seizures, medication side effects, comorbidities, and overall QoL (PIES).","definition_or_measurement_approach":"Overall impact assessed using the Personal Impact of Epilepsy Scale (PIES)."}

Planned Sample Size: 20
Recruitment Window Months: 17
Consent Approach: Subject information and informed consent forms are provided for adults, parents and 12-17-year-olds (multiple ICF/SIS documents listed: L1_SIS and ICF adults, L1_SIS and ICF parents, L1_SIS and ICF 12-17yr). Parental/guardian ICFs and 12-17-specific documents are available in the trial documents. Languages available are not specified in the record.

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