Phase 3 Epilepsy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a documented diagnosis of Lennox-Gastaut syndrome (LGS), confirmed by having more than one type of seizure (including at least one drop or stiffening seizure), a specific brainwave test (EEG) result showing patterns consistent with LGS, and a history of developmental delay
• People whose LGS began before the age of 11
• People aged 4 to 55 years old at the time of joining the trial
• People who have experienced at least 8 "drop seizures" (seizures that cause or could cause falling, slumping, or head hitting a surface) across a 4-week period before the trial starts, with at least 4 in each of the first and last two weeks
• People who have been taking 1 to 4 seizure medications at a stable dose for at least 4 weeks before the first visit
• People on a special diet for seizures (such as a ketogenic diet) or using a brain stimulation device, provided these have been stable for at least 4 weeks before the baseline period and remain stable throughout the study (these do not count as seizure medications)
• People who are not taking Epidiolex but use other cannabidiol products (the trial site's medical monitor would need to confirm whether this counts as a seizure medication)
• People who are not capable of becoming pregnant, or who agree to use an accepted form of birth control starting at least 4 weeks before the trial, during the trial, and for 4 weeks after it ends
• People whose parents or caregivers are able to keep accurate daily seizure diaries
• People (and their caregivers or legal representatives) who are willing and able to follow all trial requirements, in the opinion of the investigator
• People with a history of COVID-19 vaccination are permitted to join

Who may not be able to join:

• People whose seizures are caused by a progressive (worsening) neurological disease — though people with tuberous sclerosis may still be considered, unless a progressive brain tumour is present
• People with a significant ongoing illness affecting the heart, lungs, digestive system, kidneys, or liver, if the investigator believes this could affect safety
• People who received ACTH hormone therapy within 6 months before the baseline period
• People who have been on a special seizure diet for less than 4 weeks before the first visit, or who experience frequent loose stools
• People currently taking felbamate (a seizure medication) for less than 18 continuous months
• People currently taking vigabatrin, or who stopped taking it less than 5 months before the first visit, or who do not have documentation showing no significant vision problems linked to its use
• People who experienced a serious episode of oxygen deprivation requiring emergency resuscitation within the 12 months before the baseline period
• People who had a prolonged, severe seizure episode (status epilepticus) within 12 weeks before the first visit
• People who have had a significant illness (including COVID-19) in the 4 weeks before the first visit, as determined by the investigator
• People with significantly abnormal blood or laboratory test results at the first or second visit, in the investigator's opinion
• People with a history of a serious allergic reaction to a medication (such as severe skin reactions or a condition called DRESS syndrome) that required hospitalisation
• People who have had a brain stimulation device (such as VNS, DBS, or RNS) implanted or switched on less than 5 months before joining, whose device settings have not been stable for at least 4 weeks, or whose device battery is not expected to last the full duration of the trial
• People who are pregnant, possibly pregnant, breastfeeding, or planning to become pregnant
• People aged 6 and above (who are able to be assessed) who have had thoughts of suicide with intent or a plan within 6 months before the second visit, or any suicidal behaviour within 2 years before the second visit, as measured by a standard assessment tool
• People with significant active liver disease (mild stable elevations in certain liver enzymes may be acceptable — confirm with trial site)
• People with elevated bilirubin levels in the blood above a certain threshold, unless due to a harmless condition called Gilbert's syndrome
• People with active hepatitis B or C, confirmed by blood tests at the first visit
• People with a known positive HIV test result
• People taking Epidiolex who are also using any other cannabidiol products
• People scheduled for epilepsy surgery, a new stimulation device implant, or any other surgery during the trial period
• People who have taken part in another clinical drug or device trial within 4 weeks before the first visit
• People taking certain medications known to strongly affect how the body processes drugs — including (but not limited to) phenobarbital, phenytoin, carbamazepine, rifampin, or St. John's Wort (confirm full list with trial site)
• People with significant heart problems, including unstable chest pain, a heart attack in the past 2 years, uncontrolled heart failure, serious heart rhythm problems, or a condition called congenital short QT syndrome
• People whose heart rhythm test (ECG) shows an abnormally short or long QT interval, confirmed by a repeated test
• People who have needed rescue benzodiazepine medication (a fast-acting seizure medication) more than once a week on average in the month before the first visit
• People who have previously been treated with carisbamate, or who are known to be allergic to any ingredient in the trial's oral liquid medication

Important: Always verify eligibility with the trial site directly before applying.