Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727943
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-14
First Post:
2022-12-23
Brief Title:
Add-on Clioquinol in Drug-resistant Childhood Epilepsy an Exploratory Study
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Add-on Clioquinol in Drug-resistant Childhood Epilepsy an Exploratory Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIOKID
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
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 1mgkgday and later higher dose 4mgkgday 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 1mgkgday and the higher dose 4mgkgday 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
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 1mgkgday and the higher dose 4mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None