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

NCT05727943 | Unknown Phase 2 DMC

• 1 other identifier: S 64647
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Epilepsy Intractable

Outcome Measures

Primary Outcomes (1)

• Responder rate : seizure frequency reduction

  Percentage of 50% responders after 2 weeks and 6 weeks exposure to low (1mg/kg/day) and higher doses (4mg/kg/day) of clioquinol respectively

  8 weeks intervention

Secondary Outcomes (1)

• safety and Quality of Life assessment

  8 weeks intervention

Study Arms (1)

add - on clioquinol

EXPERIMENTAL

Add-on clioquinol to concomitant anti seizure medications. Clioquinol - magistral suspension preparation (100mg/ml) - oral intake Exposure 2 weeks to low dose: 1 mg/kg/day Exposure 6 weeks to higher dose: 4 mg/kg/day

Drug: Clioquinol

Interventions

Clioquinol DRUG

add on clioquinol to concomitant ASM

add - on clioquinol

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Well defined epilepsy history with convulsive seizures (with observable and countable motor component)
• 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.

You may not qualify if:

• Participant has a history of liver or kidney disease. Children with a co-existing active neuropathy (such as neuritis optica, transverse myelitis)
• Asian ethnicity
• Abnormal low blood level of vitamin B12 or Zn
• Patients with hypothyroidism
• Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial
• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Clioquinol

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oxyquinoline; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lieven Lagae, MD PhD

  University Hospitals, University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: February 14, 2023
• Study Start: March 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

BE (1)