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Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (StATES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03478982
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
EngageTherapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE March 16, 2018
Actual Primary Completion Date December 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Cessation of seizure activity [ Time Frame: 2 hours post-dosing ]
EEG activity recorded from the onset of a predictable seizure through two minutes post dosing with study drug and no recurrence of seizure activity within 2 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Seizure episode severity [ Time Frame: 6 hours post dosing ]
    Severity of on study episode compared on previously experienced seizures on a 5-point scale (much worse than to much better than)
  • Use of rescue medication [ Time Frame: 5 minutes post-dosing through 2 hours post-dosing ]
    Use of medication to stop a seizure that doesn't respond to study drug 5 minutes post-dose and for up to 2 hours post-dose
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 20, 2018)
Incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 6 weeks ] ]
Incidence of adverse events
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern
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 epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Staccato Alprazolam
    single dose for inhalation
    Other Name: STAP-001
  • Drug: Placebos
    single dose for inhalation
Study Arms  ICMJE
  • Experimental: Staccato Alprazolam 1.0 mg
    single dose for inhalation
    Intervention: Drug: Staccato Alprazolam
  • Experimental: Staccato Alprazolam 2.0 mg
    single dose for inhalation
    Intervention: Drug: Staccato Alprazolam
  • Placebo Comparator: Placebo
    single dose for inhalation
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
Actual Study Completion Date  ICMJE January 4, 2020
Actual Primary Completion Date December 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Male or female ≥ 18 years of age.
  3. 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
  4. 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.
  5. 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.
  6. Subject is able to comply by the requirements of the protocol, particularly the requirements and specific Institution policies during the in-clinic stay.

Exclusion Criteria:

  1. History or diagnosis of non-epileptic seizures (e.g. metabolic or pseudo-seizures).
  2. History of status epilepticus in the 6 months prior to Screening
  3. 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
  4. Use of strong CYP 3A4 inhibitors; including azole antifungal agents (e.g., etoconazole, itraconazole), nefazodone, fluvoxamine, cimetidine, HIV protease inhibitors (e.g., ritonavir)
  5. Has severe chronic cardio-respiratory disease
  6. History of HIV-positivity.
  7. Pregnant or breast-feeding.
  8. Clinically significant renal or hepatic insufficiency (hepatic transaminases >2 times the upper limit of normal (ULN) or creatinine ≥ 1.5 x ULN).
  9. History of acute narrow angle glaucoma, Parkinson's disease, hydrocephalus, or history of significant head trauma.
  10. Subjects who use medications to treat airways disease, such as asthma or COPD or have any acute respiratory signs/symptoms (e.g., wheezing).
  11. 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
  12. A history within the past 1 year of drug or alcohol dependence or abuse.
  13. 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).
  14. Known allergy or hypersensitivity to alprazolam.
  15. History of glaucoma.
  16. Subjects who currently have an active major psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study.
  17. 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.
  18. Significant hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease and congestive heart failure), endocrine, neurologic or hematologic disease.
  19. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Jamaica,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03478982
Other Study ID Numbers  ICMJE ENGAGE-E-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EngageTherapeutics, Inc.
Study Sponsor  ICMJE EngageTherapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: J. Isojarvi, MD, PhD Engage Therapeutics Inc.
PRS Account EngageTherapeutics, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP