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

• diazepam nasal spray (Drug)

Primary outcomes

• Olfactory Changes as Measured by the Smell Identification Test (SIT) [Screening, weeks 12, 24, 36, 48 and 51]: The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.
• Change From Baseline (Screening) in Nasal Mucosa. [Screening, Weeks 12, 24, 36, 48 and 51]: Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."
• Change in Taste as Measured by a Taste Change Questionnaire [Weeks 12, 24]: Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10).

Sex: All, ages: 12 Years to 65 Years

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

Participant flow

Outcome results

• Olfactory Changes as Measured by the Smell Identification Test (SIT) (Primary), Count of participants, Participants: Diazepam Nasal Spray (Adults) 18; Diazepam Nasal Spray (Adolescents) 0
• Change From Baseline (Screening) in Nasal Mucosa. (Primary), Count of participants, Participants: Adults 67; Adolescents 6
• Change in Taste as Measured by a Taste Change Questionnaire (Primary), Mean, units on a scale: Diazepam Nasal Spray (Adults) 7.7 +/- 2.73

Adverse events

Time frame: 1 year

Serious adverse events by term

Other adverse events by term

• MinJae Lee, Study director, SK Biopharmaceuticals Co, Ltd