ENROLLING NOW - 1

1. An Open label Safety and Tolerability study of chronic intermittent use of diazepam nasal spray in Adolescents and Adults having seizure Clusters.

Sponsor: Acorda Therapeutics
AEDs: At least 2 AEDs
Protocol: DZNS-EP-1025

PI: Evan Fertig, MD

Inclusion criteria:
• Adolescents and Adults ages 14 to 65 inclusive.
• Diagnosis of treatment- resistant epilepsy
• Occurrence of at least 3 seizure clusters in the past 12 months
• At least 1 seizure cluster in the past 4 months prior to screening visit
• Taking atleast 2 AEDs
• Stable on AEDs for at least 4 weeks prior to screening.

Exclusion Criteria:
• Female subject with reproductive potential doesn’t agree to use a highly effective birth control method.
• Breast feeding or pregnant or planning to get pregnant
• Clinically significant abnormalities( e.g septal perforations) or illness that would affect ability to complete study as determined by medical history, physical exam, visual evaluation of nasal septum and turbinates, ECG and clinical lab results
• Positive serology test (HBsAg, HCV antibody, HIV 1 & 2 antibody)
• Positive for drug abuse
• Suicidal within past 1 year.