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

Acorda Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Refractory Epilepsy

Treatments: Drug: diazepam nasal spray; Drug: diazepam rectal gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02474407

DZNS-EP-1019

Details and patient eligibility

About

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)

Full description

To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.

Enrollment: 78 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

diazepam nasal spray (DZNS)

Experimental group

Description:

One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.

Treatment:

Drug: diazepam nasal spray

diazepam rectal gel (DRG)

Active Comparator group

Description:

A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.

Treatment:

Drug: diazepam rectal gel