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

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Diazepam

Criteria

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