Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

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

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Diazepam

Criteria

Inclusion Criteria:

• Diagnosis of refractory epilepsy

• Body weight 26 to 111 kilogram (kg) inclusive

• Other inclusion criteria apply

Exclusion Criteria:

• Male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product

• 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

• Other exclusion criteria apply