Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lundbeck A/S
Age
1–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Onset of seizures in the first year of life
History of fever-induced prolonged seizures as determined by the Investigator
These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
Multiple seizure types which may include:
* generalised tonic-clonic (required for inclusion)
* clonic (required for inclusion)
* myoclonic jerks/seizures
* history of normal development prior to seizure onset followed by development delay or regression after seizure onset
* abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) \[Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED\] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks
You may not be if
1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
2. The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
3. The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids
4. The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed
5. The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy
Clareo Health | Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
