A study to test the safety and tolerability of Staccato alprazolam in study participants 12 years of age and older with epilepsy

JRCT ID: jRCT2061210061

Registered date:12/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Epilepsy
• Date of first enrollment: 08/12/2021
• Target sample size: 20
• Countries of recruitment: AUSTRALIA,Japan,BULGARIA,Japan,ZECH REPUBLIC,Japan,CHINA,Japan,GERMANY,Japan,HUNGARY,Japan,ITALY,Japan,POLAND,Japan,SPAIN,Japan,UKRAINE,Japan,UNITED KINGDOM,Japan,UNITED STATES,Japan
• Study type: Interventional
• Intervention(s): Participants will receive Staccato alprazolam by inhalation.

Outcome(s)

Primary Outcome

- Frequency of treatment-emergent adverse events (TEAEs)
- Frequency of TEAEs leading to withdrawal from study
- Frequency of serious TEAEs

Secondary Outcome

- Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
- Treatment success after IMP administration with no recurrence after 2 hours for seizures occurring within first 12 months
-Frequency of respiratory TEAEs

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Participant must be >=12 years of age at the time of signing informed consent
- Participant must have a study caregiver >=18 years of age at the time of signing the informed consent; the study caregiver(s) must be able to recognize and observe the participant's seizures
- Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged
seizures that includes at least 1 of the following:
a) Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
b) Episodes of a focal seizure with a minimum duration of 3 minutes
c) Episodes of a focal seizure or a flurry of myoclonic seizure for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes
- Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))

Exclude criteria

- Participant has a current history of alcohol or drug use disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparable drugs (and/or an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specific requirements)
- Participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8 weeks prior to the Screening Visit
- Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures
- Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation). NOTE: Participants with mild asthma who qualify for inclusion in the are allowed to be enrolled even though they have known airway hypersensitivity.
- Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence of hemoptysis or pneumothorax
- Participant has had a positive antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs/symptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and/or oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to Screening
- Participant has experienced a severe upper respiratory tract infection within 4 weeks or severe bronchitis/pneumonia within 3 months before the Screening Visit
- Participant has a history or presence of acute narrow-angle glaucoma
- Participant has a condition for which oral alprazolam is contraindicated
- Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone
- Participant is taking any opioids or sedative hypnotics on a chronic basis
- Participant is taking nonselective beta blockers on a chronic basis

Related Information

• Primary Sponsor: Toyota Yukihiro