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Study Summary
This trialwill assess a new epilepsy drug's effectiveness and safety in children with myoclonic-atonic seizures. Part A will assess efficacy & tolerability, Part B will assess long-term safety.
- Epilepsy-Associated Seizures (EMAS)
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 225 Patients • NCT02224560Trial Design
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- You have a seizure disorder that has not responded well to prescribed medication.If you are a female and continuing to Part B of the trial, you must take a pregnancy test before receiving the first dose of GWP42003-P. The test must confirm that you are not pregnant.You have a history of a type of seizure called infantile spasms.You have a significant developmental delay or cognitive impairment before experiencing seizures.You have a worsening neurological condition.You have to provide an EEG report from the past 12 months or be willing to undergo an EEG at the screening, to confirm a specific pattern (3 to 6 Hertz) in your brain waves.You have taken a new medication or used a medical device in a clinical trial within the past month.You have used any form of cannabis, including medicinal or recreational, or any supplements containing cannabinoids in the month leading up to screening.You have a certain type of epilepsy called EMAS or Doose syndrome that causes specific types of seizures known as myoclonic-atonic seizures. A medical history and approval by The Epilepsy Study Consortium will determine if you meet this criteria.You are taking medication or following a special diet for epilepsy and have been on a stable regimen for at least 28 days or 3 months, respectively, before starting the study. No changes to your treatment plan are allowed during the study.If you are a man with a partner who can have children and you are able to have children, you must agree to use two forms of contraception (one being a male barrier method) from the time you are screened for the study until 3 months after you finish the study.If you are a woman, you cannot be pregnant or breastfeeding during the study. You will need to provide a negative pregnancy test before starting.You had your first seizure between 6 months to 6 years of age and had normal or slightly delayed development before the seizures started. Most of your seizures in the first year were either myoclonic-atonic or generalized tonic-clonic seizures.Participants must use birth control methods that follow the guidelines set by the Clinical Trial Facilitation Group (CTFG) and any local regulations.Women must take a pregnancy test before they start taking the medicine. They must not be pregnant.You have a history of non-epileptic seizures that may make it difficult to accurately measure the effectiveness of the treatment.You have a medical condition that is not stable and could cause complications during the study, except for EMAS.You had a major illness within the past 28 days before the screening or randomization visits that could impact your seizure frequency. However, epilepsy will not be considered in this exclusion criterion.You have a history of alcohol or drug abuse.You have any other serious health problems that could put you or others at risk during the study, affect the study's results, or impact your ability to participate.You had surgery for epilepsy within the last six months.You are planning to have surgery for epilepsy or any other procedure that requires general anesthesia during the study.You started a special diet called ketogenic diet in the last 3 months. If you have been on a stable ketogenic diet or similar diet for at least 3 months and are willing to continue it during the study, you can participate.You are currently using illegal drugs or taking prescription medication without a doctor's prescription.If you are a breastfeeding mother, you cannot use any cannabis-related products, including recreational or medicinal cannabis, for 28 days before the screening.If you are between 4 to 18 years old, you have had serious thoughts about harming yourself or have attempted to do so, as determined by a suicide rating scale.
- Group 1: Placebo
- Group 2: GWP42003-P
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there an age limit for participants in this particular research project?
"In order to take part in this research, potential participants must be aged 1-18. Out of the total 316 clinical trials, 126 are for people under 18 years old and 190 are for those over 65."
Are there any safety concerns associated with taking GWP42003-P?
"There is existing data that suggests GWP42003-P's efficacy and safety, so it was given a score of 3."
Are there any open slots for new volunteers in this clinical trial?
"Indeed, the most recent information available on clinicaltrials.gov points to this trial recruiting patients as we speak. This particular study was first advertised on October 31st 2020 and updated November 14th 2020. There is a need for 240 individuals at 1 site location."
How many individuals can join this clinical trial?
"The information available on clinicaltrials.gov verifies that this study is currently recruiting patients. The trial was posted on October 31st, 2020 and updated two weeks ago on November 14th. They are looking for a total of 240 subjects at a single location."
For whom is this trial designed?
"This trial is looking for 240 participants that suffer from seizures and are between 1 year old to 18 years old. Eligibility requirements include the following: contraceptive use by both male and female participants must follow Clinical Trial Facilitation Group (CTFG) guidelines, females cannot be pregnant or lactating, have a negative serum pregnancy test at Screening , confirmed negative urine pregnancy test before receiving IMP at Part A Visit 3, continuing to Part B with a negative urine pregnancy test result before receiving GWP42003-P, diagnosis of epilepsy with myoclonic-atonic seizures consistent with ILAE guidelines, initial seizure onset occurred 6 months to"
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