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