Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurelis, Inc.
• Treatments: Diazepam

Criteria

Inclusion Criteria:

• Subject has a clinical diagnosis of epilepsy and, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control.

• Subjects having either partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness, for which rescue medications are used at least once per month for the last 3 months.

Exclusion Criteria:

• Subjects whose body weight are < 6 kg or > 33 kg.

• Subject is undergoing intracranial electroencephalogram (EEG) monitoring.

• A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non-seasonal allergies, nasal polyps or any nasal passage abnormality.

• Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.

• Participation in a clinical trial within 30 days prior to the first dose of study drug.

• Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.