Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Epilepsy Patients With Cluster Seizures – Protocol DZNS-EP-1025.
ClinicalTrials.gov Identifier: NCT02316847
• Diagnosis of drug-resistant epilepsy
• Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
• Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
• A caregiver must consent to participate together with the subject for purposes of observation and data collection
• The caregiver must be present when the investigational product is administered
• Screening body weight between 26 to 111 kg, inclusive
• Female subject who is pregnant, breastfeeding, or planning to become pregnant
• Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
• Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
• Positive screening test for ethanol or other drugs of abuse
• Unable to receive medications intranasally
David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720