An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.

Acorda Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Epilepsy

Treatments: Drug: diazepam nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02316847

DZNS-EP-1025

Details and patient eligibility

About

This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).

Enrollment: 126 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of drug-resistant epilepsy
• Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
• Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
• A caregiver must consent to participate together with the subject for purposes of observation and data collection
• The caregiver must be present when the investigational product is administered
• Screening body weight between 26 to 111 kg, inclusive

Exclusion criteria

• 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
• Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
• Positive screening test for ethanol or other drugs of abuse
• Unable to receive medications intranasally

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

diazepam nasal spray (Adults)

Experimental group

Description:

One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.

Treatment:

Drug: diazepam nasal spray

Diazepam Nasal Spray (Adolescents)

Experimental group

Description:

One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.

Treatment:

Drug: diazepam nasal spray