Last updated on January 2019

Assessment of Pharmacokinetics and Safety of Diazepam Buccal Soluble Film in Pediatric Patients


Brief description of study

The hypothesis of the study is that DBSF will be safe and tolerable in pediatric patients during the Interictal state (Period A) and the ictal/peri-ictal state (Period B) of Epilepsy, and pharmacokinetics will be the same during and in-between experiencing seizures.

Detailed Study Description

This is a Multicenter , Open Label Crossover study to assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Pediatric patients with Epilepsy.

The Primary objective of the study is to assess the pharmacokinetics of DBSF in pediatric patients with epilepsy in interictal State (Period A) and ictal/peri-ictal state (Period B).

Subjects are considered to be in interictal state if an interval of at least 3 hours has elapsed since any clinical observable postictal signs or symptoms (from the last observed seizure) and the subject has been seizure free over this period.

For the purposes of this study, the ictal state is defined as an ongoing clinically observable seizure or seizure activity as verified via EEG. The peri-ictal state is defined clinically as the subjects's immediate postictal state following a generalized tonic-clinic (GTC) seizure or focal seizure with impaired awareness , and within 5 minutes following the last clonic jerk.

The secondary objectives include a) Evaluate the safety/tolerability of DBSF in pediatric subjects with epilepsy. b) Evaluate the usability of DBSF.

The minimum study duration will be approximately 35 day, with a maximum of approximately 58 days , consisting of 1) screening period 2)Treatment Period A 3)Treatment Period B and 4) Follow up visit.

Blood samples will be drawn during the entire study for assessing the pharmacokinetics of the DBSF.

Clinical Study Identifier: NCT03222349

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