Study on Cannabidiol and Dronabinol for Children with Refractory Epilepsy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for children with refractory epilepsy, a type of epilepsy that does not respond well to standard treatments. The treatment being tested is called TA-CBD 10, which is an oral liquid containing two active substances: dronabinol and cannabidiol. These substances are derived from cannabis and are being investigated for their potential to reduce seizures in children who have not found relief with other medications.

The purpose of the study is to compare the effectiveness of TA-CBD 10 with a placebo in reducing seizure frequency. Participants in the study will receive either the active treatment or a placebo over a period of time. The study will monitor changes in seizure frequency and assess the overall impact on the quality of life for the children involved. The trial will also look at various aspects of the children’s health and behavior, including sleep patterns and any side effects that may occur.

Throughout the study, participants will be closely observed to ensure their safety and to gather data on how the treatment affects their condition. The trial aims to provide valuable insights into whether TA-CBD 10 can be a beneficial addition to the treatment options available for children with refractory epilepsy.

1 joining the study

The study involves children aged 1 to 18 years with a confirmed diagnosis of refractory epilepsy. The child must have experienced at least four seizures during a four-week period before the study begins.

All current epilepsy medications must have been stable for at least one month before starting the study. A caregiver must be available to provide reports during the study.

2 baseline period

During this period, the frequency of seizures is recorded to establish a baseline for comparison. This helps in assessing the effectiveness of the treatment.

3 treatment phase

Participants receive either TA-CBD 10 or a placebo. Both are administered as an oral liquid. The specific dosage and frequency are determined by the study protocol.

The main goal is to compare the change in seizure frequency between the periods when the active treatment is given and when the placebo is administered.

4 evaluation of primary outcomes

The primary outcome is the change in daily seizure frequency from the baseline during the placebo and active treatment periods.

5 evaluation of secondary outcomes

Secondary outcomes include changes in quality of life, severity of epilepsy, and behavior. These are measured using various scales and questionnaires.

Other assessments include the number of adverse events, clinical characteristics, and measurements of brain activity using EEG and TMS-EMG.

6 end of study

The study is expected to conclude by June 2027. At the end of the study, all collected data will be analyzed to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

The patient must be at least 1 year old and no older than 18 years old.
The patient must have a confirmed diagnosis of refractory epilepsy. This means their epilepsy does not respond well to treatment.
The patient must have had at least 4 seizures that can be counted (not all on the same day) during a 4-week period before the study starts, while taking at least one anti-seizure medication (ASM).
All medications or treatments for epilepsy must have been at a stable dose for one month before the study begins, and the patient must be willing to keep the same medication routine during the study.
The legal representative or parents of the patient must give their informed consent, which means they agree to the patient participating in the study after understanding what it involves.
There must be a caregiver available who can consistently provide information about the patient during the study.

Who Cannot Join the Study?

Individuals who are not diagnosed with refractory epilepsy. This means the epilepsy does not respond well to treatment.
Individuals who are not within the specified age range for the study.
Individuals who are not able to follow the study procedures or take the study medication as required.
Individuals who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Individuals who are pregnant or breastfeeding.
Individuals who are participating in another clinical trial at the same time.
Individuals who have a history of substance abuse or addiction.
Individuals who have allergies or sensitivities to the study medication or its ingredients.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Kempenhaeghe	Heeze	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Epilepsie Instellingen Nederland Stichting	Zwolle	The Netherlands
Enpdrky Uurndiwoyujl Muuwczc Cewqyja Rcpevfymg (kbkqqad Mqy	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Cannabidiol (CBD) is being studied as an additional treatment for children with epilepsy that does not respond to other treatments. The goal is to see if adding CBD can help reduce the frequency or severity of seizures in these children.

Refractory Epilepsy – Refractory epilepsy is a condition where seizures are not controlled despite treatment with at least two different anti-seizure medications. It is characterized by frequent and unpredictable seizures that can vary in type and severity. The condition can significantly impact daily life, affecting activities, mood, and cognitive functions. Over time, individuals may experience changes in seizure patterns, and the condition may become more challenging to manage. The underlying causes can include genetic factors, brain injuries, or developmental disorders. Managing refractory epilepsy often requires a comprehensive approach to reduce seizure frequency and improve quality of life.

Trial ID:

2023-507843-12-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Cannabidiol and Dronabinol for Children with Refractory Epilepsy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?