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Study Summary
This trial will study a new seizure medication to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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Who is running the clinical trial?
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- I have seizures that aren't controlled even though I'm on medication.You have important irregularities in your heart's electrical activity as shown on an ECG test.You had an appropriate VEEG test within the past year.I have been diagnosed with Tuberous Sclerosis Complex according to the 2012 guidelines.My seizures are not fully controlled by my current medication.My epilepsy diagnosis aligns with international guidelines and has been confirmed by a specialist group.My child is between 1 month and 2 years old and has TSC, DS, or LGS.You have important abnormal test results, according to the doctor.My liver is not working well.I have heart conditions that may affect ECG test results.
- Group 1: GWP42003-P
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are we enrolling participants for this experiment at this time?
"Yes, this study is still looking for participants and was originally posted on May 19th, 2021. The most recent update to the study was made on July 6th, 2022."
Could you tell me if patients who are younger than 30 can join this particular research project?
"Eligibility for this clinical study starts at 1 month old and caps at 11 months old."
Does this research project have any inclusion or exclusion criteria?
"This clinical trial is looking for 12 participants who currently have sclerosis and are between the ages of 1 month and 11 months. Additionally, participants must meet the following criteria:- Must be 1 month to < 12 months of age at the time of initial informed consent- Parent(s)/legal representative is/are willing and able to give informed consent for participation in the trial.- Parent(s)/legal representative is/are willing and able (in the investigator's opinion) to comply with all trial requirements (including accurate electronic participant-reported outcome [ePRO] diary completion).- Must have a clinical diagnosis"
What does the FDA's stance on SOC look like?
"SOC has been studied in Phase 3 trials, so there is some evidence to support both its efficacy and safety."
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