Multi-center, Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Adolescents and Adult Patients With Cluster Seizures, Including Assessment of Olfaction and Reported Changes in Taste.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 33
- 主要终点
- Olfactory Changes as Measured by the Smell Identification Test (SIT)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
diazepam nasal spray (Adults)
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.
干预措施: diazepam nasal spray (Drug)
Diazepam Nasal Spray (Adolescents)
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.
干预措施: diazepam nasal spray (Drug)
结局指标
主要结局
Olfactory Changes as Measured by the Smell Identification Test (SIT)
时间窗: 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.
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点