Status:
COMPLETED
Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Lead Sponsor:
Engage Therapeutics, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with e...
Eligibility Criteria
Inclusion
- Subject is able to provide, personally signed, and dated informed consent to participate in the study or will have a legally authorized representative sign the informed consent on his or her behalf before completing any study related procedures.
- Male or female ≥ 18 years of age.
- Has an established diagnosis of focal or generalized epilepsy or focal and generalized epilepsy with a documented history of predictable seizure episodes that includes at least one of the following:
- Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum duration of 5 minutes
- Episodes of a prolonged focal seizure with a minimum duration of 3 minutes
- Episodes of multiple (≥2) seizures within a 2-hour time period
- Prior to randomization, has experienced ≥4 seizure episodes with predictable pattern during the last 4 weeks (qualification period) and no more than one week without a predictable seizure episode before entry into the in-patient unit.
- Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide,intrauterine device (IUD), surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
- Subject is able to comply by the requirements of the protocol, particularly the requirements and specific Institution policies during the in-clinic stay.
Exclusion
- History or diagnosis of non-epileptic seizures (e.g. metabolic or pseudo-seizures).
- History of status epilepticus in the 6 months prior to Screening
- Has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 3 months
- Use of strong CYP 3A4 inhibitors; including azole antifungal agents (e.g., etoconazole, itraconazole), nefazodone, fluvoxamine, cimetidine, HIV protease inhibitors (e.g., ritonavir)
- Has severe chronic cardio-respiratory disease
- History of HIV-positivity.
- Pregnant or breast-feeding.
- Clinically significant renal or hepatic insufficiency (hepatic transaminases \>2 times the upper limit of normal (ULN) or creatinine ≥ 1.5 x ULN).
- History of acute narrow angle glaucoma, Parkinson's disease, hydrocephalus, or history of significant head trauma.
- Subjects who use medications to treat airways disease, such as asthma or COPD or have any acute respiratory signs/symptoms (e.g., wheezing).
- Use of any investigational drug within 30 days or 5 half-lives of the investigational drug prior to administration of study medication, whichever is longer
- A history within the past 1 year of drug or alcohol dependence or abuse.
- Positive urine screen for drugs of abuse at Screening.(positive Cannabis/Cannabinol results are acceptable if there is a documented history of stable use for medical purposes).
- Known allergy or hypersensitivity to alprazolam.
- History of glaucoma.
- Subjects who currently have an active major psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study.
- Hypotension (systolic blood pressure ≤90 mm Hg, diastolic blood pressure ≤50 mm Hg), or hypertension (systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥100 mm Hg) measured while seated at screening or baseline.
- Significant hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease and congestive heart failure), endocrine, neurologic or hematologic disease.
- Subjects who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the stability or capability of the subject to comply with the trial requirements.
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2020
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03478982
Start Date
March 16 2018
End Date
January 4 2020
Last Update
February 3 2021
Active Locations (67)
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1
UAB Hospital
Birmingham, Alabama, United States, 35294
2
University of Arizona
Phoenix, Arizona, United States, 85006
3
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
4
Clinical Trials Inc
Little Rock, Arkansas, United States, 72205