An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray in Adolescents and Adults With Cluster Seizures

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Matthew Hoerth, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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