ENROLLING NOW - 2
2. An Open-Label, Randomized, Crossover Pharmacokinetic study to determine relative Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat) in patients with Refractory Epilepsy.
Protocol: DZNS-EP-1019
Acorda Pharmacuticals
PI: Eric Segal, MD
Key Inclusion Criteria:
* Age 12 to 65 male or female.
* Diagnosis of refractory epilepsy ( i.e per Kwan definition: have failed at least 2 AED regimen) taking at least one concomitant AED; Epilepsy characterized by the presence of seizures with an alteration of consciousness in the peri-ictal period.
* Cohort 2: Multiple daily seizures (on at least 24 of the last 28 days; and at least 36 seizures over the last 28 days) including approximately one daily seizure with an alteration of consciousness in the peri-ictal period, as documented on the Seizure Identification Form and Seizure diary.
* All men and women of childbearing potential must agree to practice an acceptable method of birth control during the study and until 3 months after their last dose of nasal spray.
* Screening body weight 26 to 111 kg inclusive
* Adequate cognitive function to understand and sign the IRB-approved ICF (for adults) and assent ( for adolescent), or parental or legally authorized representative (LAR)
Exclusion Criteria:
* History of an illness that may affect the absorption, distribution, metabolism or elimination of diazepam.
* Known allergy to diazepam
* Current use of cigarettes, e cigarettes, cigars, chewing tobacco, pipe or snuff tobacco OR use within 2 weeks prior to screening
* Clinically significant LFTs
* Nasal Septal abnormalities
* Positive serology test ( HBs Ag, HCV antibody, HIV1 and 2 antibodies)
* History of Alcohol or drug abuse in the past 1 year
* Positive screening test for ETOH, cocaine, amphetamines, Phencyclidine or methadone.
* Suicidality within a yr prior to screening
* Participation in a drug trial within 4 weeks of screening.
* History of acute angle Glaucoma
* Unable to receive medications intranasally or rectally
Visits 3 and 4 with 14 days interval will be conducted at TKL research facility.
Length of stay per admission: 2 nights