A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Overview

Información sobre este estudio

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion 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:

1. Generalized seizure episodes starting with a flurry of absence seizures or
myoclonic seizures with a minimum total duration of 5 minutes

2. Episodes of a focal seizure with a minimum duration of 3 minutes

3. Episodes of a focal seizure or a flurry of myoclonic seizures 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

Exclusion 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 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 and/or acute
respiratory signs/symptoms

- Participant has a clinically significant chronic pulmonary disorder and/or recent
history or presence of hemoptysis or pneumothorax

- Participant has ever been diagnosed with asthma (irrespective of current treatment)

- 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

- Participant has a forced expiratory volume in 1 second (FEV1) <80 % of (FEV1) as
measured via spirometry at the Screening Visit

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

William Tatum, D.O.

Abierto para la inscripción

Contact information:

Doriana Boro

Boro.Doriana@mayo.edu

More information

Publicaciones

Publications are currently not available