EpilepsyPhase 2StATESNCT03478982
Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
A Phase 2 study testing Staccato Alprazolam in people with Epilepsy, run by Engage Therapeutics, Inc. at 67 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Staccato Alprazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 67 sitesin 3 countries
- Study dates
- 16 Mar 2018to 4 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
67 sites in 3 countries.
67 sites in 3 countries
United States63 sites
Dent Neurologic Institute
Amherst, New York, 14226
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Mid-Atlantic Epilepsy And Sleep Center, LLC
Bethesda, Maryland, 20817
UAB Hospital
Birmingham, Alabama, 35294
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, 02115
SUNY Downstate Medical Center - Comprehensive Epilepsy Center
Brooklyn, New York, 11203
Kaleida Health Oishei Children's Hospital
Buffalo, New York, 14203
Carolinas Neurosciences Institute
Charlotte, North Carolina, 28207
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
OnSite Clinical Solutions, LLC
Concord, North Carolina, 28025
University of Texas Southwestern Medical Center - Neurology Clinic
Dallas, Texas, 75390
Rancho Research Institute Inc.
Downey, California, 90242
JFK Medical Center
Edison, New Jersey, 08820
NW FL Clinical Research Group LLC
Gulf Breeze, Florida, 32561
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
UT Houston
Houston, Texas, 77030
Clinical Trial Network
Houston, Texas, 77074
University of Florida Health Science Center Jacksonville
Jacksonville, Florida, 32209
Mayo Clinic Florida
Jacksonville, Florida, 32224
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
University of Kansas Medical Center
Kansas City, Kansas, 66160
Impact Clinical Trials Las Vegas
Las Vegas, Nevada, 89106
Clinical Trials Inc
Little Rock, Arkansas, 72205
Institute of Neurology & Neurosurgery at St. Barnabas
Livingston, New Jersey, 07039
UCLA
Los Angeles, California, 90095
Centra Medical Group Neurology Center
Lynchburg, Virginia, 24502
Clinical Translational Research Site
Miami, Florida, 33136
Advanced Pharma Cr, LLC
Miami, Florida, 33147
Nicklaus Children's Hospital
Miami, Florida, 33155
Rutgers University
New Brunswick, New Jersey, 08901
Yale University
New Haven, Connecticut, 06511
Ochsner Health System
New Orleans, Louisiana, 70121
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Mount Sinai Health System
New York, New York, 10029
Lenox Hill Hospital
New York, New York, 10075
Hoag Hospital
Newport Beach, California, 92663
Center for Rare Neurological Diseases
Norcross, Georgia, 30093
AdventHealth Orlando
Orlando, Florida, 32803
Research Institute of Orlando, LLC
Orlando, Florida, 32806
Stanford Neuroscience Health Center
Palo Alto, California, 94304
NeuroMedical Research Institute
Panama City, Florida, 33607
Havana Research Institute LLC.
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Lewis Katz School of Medicine at Template University
Philadelphia, Pennsylvania, 19140
University of Arizona
Phoenix, Arizona, 85006
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University - Brain Institute - Comprehensive Epilepsy Center
Portland, Oregon, 97239
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah Hospital
Salt Lake City, Utah, 84132
Maine Medical Center
Scarborough, Maine, 04074
Washington University School of Medicine
St Louis, Missouri, 63110
Clinical Research Institute
Stockbridge, Georgia, 30281
Multi-Care Institute for Research and Innovation
Tacoma, Washington, 98405
The Promedica-University of Toledo Neuroscience Center
Toledo, Ohio, 43606
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
SRI International
West Bloomfield, Michigan, 48322
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Australia3 sites
Austin Hospital
Heidelberg, Victoria, 3084
The Alfred
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
About this study
Official title: A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern
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).
- Conditions
- Epilepsy
- Being tested
- Staccato Alprazolam, Placebos
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staccato AlprazolamDrug
Also called STAP-001
single dose for inhalation
PlacebosDrug
single dose for inhalation
| Study group | Role | What they receive |
|---|---|---|
| Staccato Alprazolam 1.0 mg | Experimental | single dose for inhalation Receives: Drug: Staccato Alprazolam |
| Staccato Alprazolam 2.0 mg | Experimental | single dose for inhalation Receives: Drug: Staccato Alprazolam |
| Placebo | Placebo comparator | single dose for inhalation Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours
Percentage of participants with onset of a predictable seizure through 2 minutes post dosing with study drug and no recurrence of seizure activity within 2 hours were reported for each treatment group based on clinical observation.
Measured: 2 hours post-dosing on dosing day
Secondary outcomes (3)
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Severity of on study seizure episode compared to previously experienced seizures was assessed with Seizure Episode Severity Scale. It is a 5-point scale with range from 1 to 5, where 1 indicates much worse than and 5 indicates much better than.
Measured: 6 hours post-dosing on dosing day
Percentage of Participants With Use of Rescue Medication
Percentage of participants with use of rescue medication to stop a seizure episode at the discretion of the principal investigator were reported.
Measured: 2 hours post-dosing on dosing day
Percentage of Participants With Secondary Generalization (Evolution to a Complex Partial Seizure and/or a Generalized Tonic-Clonic Seizure)
Percentage of participants who had seizures that evolved to a complex partial seizure and/or a generalized tonic-clonic seizure were reported.
Measured: 24 hours post-dosing on dosing day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start16 Mar 2018
- Primary completion22 Dec 2019
- Study completion4 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Isojarvi, MD, PhD, Study chair, Engage Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478982
- Sponsor's protocol ID
- ENGAGE-E-001
- Acronym
- StATES
- Status last verified
- Feb 2021
- First submitted
- 7 Mar 2018
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Publications
French J, Biton V, Dave H, Detyniecki K, Gelfand MA, Gong H, Liow K, O'Brien TJ, Sadek A, DiVentura B, Reich B, Isojarvi J. A randomized phase 2b efficacy study in patients with seizure episodes with a predictable pattern using Staccato(R) alprazolam for rapid seizure termination. Epilepsia. 2023 Feb;64(2):374-385. doi: 10.1111/epi.17441. Epub 2022 Dec 7.
PubMed 36268811
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern
- ClinicalTrials.gov ID
- NCT03478982
- Acronym / sponsor ID
- StATES / ENGAGE-E-001
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Engage Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 4 Jan 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staccato Alprazolam 1.0 mg | Experimental | Drug: Staccato Alprazolamsingle dose for inhalation |
| Staccato Alprazolam 2.0 mg | Experimental | Drug: Staccato Alprazolamsingle dose for inhalation |
| Placebo | Placebo comparator | Drug: Placebossingle dose for inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staccato AlprazolamAlso: STAP-001single dose for inhalation | Drug | Staccato Alprazolam 1.0 mg, Staccato Alprazolam 2.0 mg |
| Placebossingle dose for inhalation | Drug | Placebo |
Primary outcome
Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours
Time frame: 2 hours post-dosing on dosing day
Percentage of participants with onset of a predictable seizure through 2 minutes post dosing with study drug and no recurrence of seizure activity within 2 hours were reported for each treatment group based on clinical observation.
3 secondary outcomes
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Time frame: 6 hours post-dosing on dosing day
Percentage of Participants With Use of Rescue Medication
Time frame: 2 hours post-dosing on dosing day
Percentage of Participants With Secondary Generalization (Evolution to a Complex Partial Seizure and/or a Generalized Tonic-Clonic Seizure)
Time frame: 24 hours post-dosing on dosing day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36268811French J, Biton V, Dave H, Detyniecki K, Gelfand MA, Gong H, Liow K, O'Brien TJ, Sadek A, DiVentura B, Reich B, Isojarvi J. A randomized phase 2b efficacy study in patients with seizure episodes with a predictable pattern using Staccato(R) alprazolam for rapid seizure termination. Epilepsia. 2023 Feb;64(2):374-385. doi: 10.1111/epi.17441. Epub 2022 Dec 7.
- Individual participant dataSharing planned: Yes. Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Isojarvi, MD, PhD study chair
Engage Therapeutics, Inc.
67 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Staccato Alprazolam in people with Epilepsy, run by Engage Therapeutics, Inc. at 67 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Australia, Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours (time frame: 2 hours post-dosing on dosing day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03478982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.