Status:
WITHDRAWN
Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies
Lead Sponsor:
MGC Pharmaceuticals d.o.o
Conditions:
Resistant Epilepsy, Drug
Adolescent Epilepsy
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
EudraCT: 2018-003887-29 Objective:To evaluate the safety and efficacy of: MGCND00EP1 from MGC PHARMACEUTICALS d.o.o. Study Design: Randomized, double blind, placebo controlled parallel grouped study...
Detailed Description
Subjects on regular therapy with anti-epileptic medications who have evidence from clinical monitoring that current therapy is insufficient, following failure of at least two AEDs for at least during ...
Eligibility Criteria
Inclusion
- Patient has documented clinically confirmed diagnosis of epilepsy;
- Patient did not respond to at least 2 AED's therapy given in adequate doses;
- Patients current therapy is considered inadequate (not completely controlled by AEDs); patients had four or more countable seizures with a motor component per 4 week period;
- Patient is aged 1 year - 18 years inclusive at screening age;
- Patient took one or more AEDs treatment at dose which has been stable for at least 4 weeks before enrolment;
- Females of childbearing potential can only participate in the study if willing to use acceptable, effective methods of contraception during the trial and for three month after end of trial participation as defined in point 7.10 of this protocol;
- Patient/parent is able to read/understand informed consent.
- Male patients must either be surgically sterile or he and his female spouse/partner who is of childbearing potential must be willing to use highly effective methods of contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study.
- All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation (VNS) were stable for four weeks prior to screening and participants were willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments are not counted as an AED.
Exclusion
- Known history or presence of clinically significant unstable medical condition other that epilepsy which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known history or presence of serious cardiovascular disease
- Known or suspected history or family history of: schizophrenia, or other psychotic illness, severe personality disorder or other significant psychiatric disorder.
- Known or suspected allergy hypersensitivity or idiosyncratic reaction to cannabinoids or any other drug substances with similar activity or to any of the excipients of the IMP.
- Participant has clinically relevant abnormalities in the 12-lead electrocardiogram measured at screening or randomisation.
- Patients were currently using or had in the past used recreational or medicinal cannabis or synthetic CBD based medications or preparations within last 3 months or had previous or current treatment with cannabis-based therapy within last 3 months.
- History of drug or alcohol addiction requiring treatment.
- History of malabsorption within the last year or presence of clinically significant gastrointestinal disease or surgery that may affect drug bioavailability, including but not limited to cholecystectomy.
- Presence of hepatic or renal dysfunction.
- Females who: are pregnant (serum hCG level consistent with pregnancy diagnosis); or are lactating;
- Participation in a clinical trial that involved administration of an investigational medicinal product within 90 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results;
- Participant has clinically significant abnormal laboratory values (e.g. liver enzymes);
- Participant has clinically significant findings from a physical examination (fever);
- In case of ketogenic diet or VNS; the diet need to be stable for at least 4 weeks, and VNS ramping needs to be stable at least 12 weeks before enrolment.
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04406948
Start Date
May 30 2024
End Date
May 30 2024
Last Update
June 3 2024
Active Locations (2)
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1
Schneider Children's Medical Center of Israel
Petach Tikvah, Central District, Israel, 4920235
2
University Children's Hospital Ljubljana University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000