Open-label Lennox Gastaut Syndrome study recruiting

ages 2 yrs to < 6 yrs old only.

The Investigational product is being evaluated in a Pharmacokinetic study at

the below US sites.

Potential subjects are required to meet certain criteria

(the full criteria can be found in the following link:

 https://clinicaltrials.gov/ct2/show/study/NCT03731715)

 

An abbreviated list of criteria is below:

Inclusion Criteria:

  • Diagnosis of LGS as evidenced by the following:

    • More than 1 type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic), for ≥6 months before Visit 1

    • Previous electroencephalogram reporting diagnostic criteria for LGS(abnormal background activity accompanied by slow spike-and-wave pattern <2.5 Hz)

  • Male or female aged ≥2 years at the time of consent

  • Aged <11 years at the onset of LGS

  • Receiving 1 to 3 concomitant AEDs at a stable dose for ≥30 days before Visit 1(vagal nerve stimulation [VNS] and ketogenic diet, stable and ongoing for ≥30days before Visit 1, do not count as AEDs)

  • Body weight ≥8 kg for subjects enrolled in Cohort IV

  • Subjects with an implanted vagal nerve stimulator will be allowed if the vagal nerve stimulator was implanted at least 5 months prior to Visit 1 (Screening) and the stimulator parameters are not changed for 30 days prior to Visit 1 and for the duration of the study

  • Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Visit 1 (Screening) and will remain stable for the duration of the study

Exclusion Criteria:

  • Progressive neurological disease

  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational medicine product

  • Scheduled for surgery during the study

  • Ketogenic diet or VNS, unless stable and ongoing for ≥30 days before Visit

  • Status epilepticus within 12 weeks of Visit 1

  • Felbamate for <1 year (subjects taking felbamate for ≥1 year must have astable dose for 60 days before Visit 1)

  • Concomitant use of vigabatrin or other medications known to be inducers ofCYP3A

  • Use of drugs known as UGT inducers, e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine

  • Use of cannabinoids (any form) and medical or recreational marijuana. Use of cannabidiol ≤ 14 days before Screening

  • Significant clinical laboratory abnormalities, including elevation of serum AST or ALT more than 1.5 times ULN for age group, or any elevation of bilirubin or creatinine about the ULN for age group at Screening

  • Intermittent use of benzodiazepine of >4 single administrations in the month prior to Screening (except for rescue treatments

Subjects must be able to receive study medication orally.

Subjects will be required to have blood draws throughout the 87 day study

treatment period. The critical PK blood draws for subjects aged 2 to <6 years will be

on Day 1: 4 blood draws and Day 17: 2 blood draws. At the conclusion of the study,

all subjects will have the opportunity to roll over into an open-label safety extension

study.

Caregivers will be required to maintain daily dosing and seizure diaries.

Participating Sites:

Information on clinical trials is provided as a service to our LGS families and posting information about trials does not imply endorsement of any company or product.

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