- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727943
Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study (CLIOKID)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this exploratory phase 2 trial, adolescents with DRE will be exposed to clioquinol add-on for a period of maximum 8 weeks (2 weeks low dose, 6 weeks higher dose). During the trial concomitant anti-epileptic medication will be kept stable, so that only the add-on effect of clioquinol will be assessed. During a prospective baseline of 2 weeks, the number of seizures will be counted. The effect of first low dose (1mg/kg/day) and later higher dose (4mg/kg/day) of clioquinol on seizure frequency will be calculated using the typical epilepsy trial outcome measures: percent reduction of seizure frequency and number of patients with a >50% seizure frequency reduction ('responders').
PK samples will be collected in the first 4 patients pre-dose and 2, 4 and 8 hours post-dose, both at initiation of the lower dose (1mg/kg/day) and the higher dose (4mg/kg/day) and on visit 4. The obtained PK data will be compared with the available literature data. Since we cannot define 'absolute' PK values (yet), we use a relative stopping rule in this first phase. If >1 of the first 4 patients show a PK pattern which is more than 50% different (max PK values 50% above literature max values), the study will be ended in these 4 patients. If the dosages need to be changed for the following patients, a protocol amendment will be provided to the FAGG and the EC. In the following subjects, a simplified PK study will be done at both dosages to examine whether they follow the findings in the 4 exploratory patients. Here also, a stopping rule when the PK data is more than 50% higher than the PK data obtained in the first 4 patients will be used.
Not only the effect of the drug on seizure frequency will be calculated, but also the effect on seizure severity, overall impact of seizures, medication side effects, comorbidities, and overall QoL, using standardized questionnaires (NHS3 and PIES) (1, 2).
The main hypothesis of the study is that 30% of the included patients will be responders and that the median seizure frequency reduction will be at least 30%. These numbers are based on very similar trial results with new anti-epileptic drugs in drug-resistant childhood epilepsy.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Leuven, Belgium, 3000
- University Hospitals UZ Leuven
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: add - on clioquinol
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 |
add on clioquinol to concomitant ASM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responder rate : seizure frequency reduction
Time Frame: 8 weeks intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety and Quality of Life assessment
Time Frame: 8 weeks intervention
|
Safety during trial (systematic recording of adverse events) . |
8 weeks intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lieven Lagae, MD PhD, University Hospitals, University of Leuven
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S 64647
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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