Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Public ClinicalTrials.gov record NCT03478982. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03478982
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 156 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 16, 2018 (Actual)
- Primary completion
- Dec 22, 2019 (Actual)
- Completion
- Jan 4, 2020 (Actual)
- Last update posted
- Feb 3, 2021
2018 – 2020
United States locations
- U.S. sites
- 63
- U.S. states
- 29
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35294 | — |
| University of Arizona | Phoenix | Arizona | 85006 | — |
| St. Joseph's Hospital and Medical Center - Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Clinical Trials Inc | Little Rock | Arkansas | 72205 | — |
| Rancho Research Institute Inc. | Downey | California | 90242 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Hoag Hospital | Newport Beach | California | 92663 | — |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | — |
| Havana Research Institute LLC. | Pasadena | California | 91105 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| NW FL Clinical Research Group LLC | Gulf Breeze | Florida | 32561 | — |
| University of Florida Health Science Center Jacksonville | Jacksonville | Florida | 32209 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Clinical Translational Research Site | Miami | Florida | 33136 | — |
| Advanced Pharma Cr, LLC | Miami | Florida | 33147 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Research Institute of Orlando, LLC | Orlando | Florida | 32806 | — |
| NeuroMedical Research Institute | Panama City | Florida | 33607 | — |
| Center for Rare Neurological Diseases | Norcross | Georgia | 30093 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Ochsner Health System | New Orleans | Louisiana | 70121 | — |
| Maine Medical Center | Scarborough | Maine | 04074 | — |
| Mid-Atlantic Epilepsy And Sleep Center, LLC | Bethesda | Maryland | 20817 | — |
| Harvard Medical School - Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| SRI International | West Bloomfield | Michigan | 48322 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Impact Clinical Trials Las Vegas | Las Vegas | Nevada | 89106 | — |
| JFK Medical Center | Edison | New Jersey | 08820 | — |
| Institute of Neurology & Neurosurgery at St. Barnabas | Livingston | New Jersey | 07039 | — |
| Rutgers University | New Brunswick | New Jersey | 08901 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| SUNY Downstate Medical Center - Comprehensive Epilepsy Center | Brooklyn | New York | 11203 | — |
| Kaleida Health Oishei Children's Hospital | Buffalo | New York | 14203 | — |
| 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 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Carolinas Neurosciences Institute | Charlotte | North Carolina | 28207 | — |
| OnSite Clinical Solutions, LLC | Concord | North Carolina | 28025 | — |
| The Promedica-University of Toledo Neuroscience Center | Toledo | Ohio | 43606 | — |
| Oregon Health & Science University - Brain Institute - Comprehensive Epilepsy Center | Portland | Oregon | 97239 | — |
| 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 Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| University of Texas Southwestern Medical Center - Neurology Clinic | Dallas | Texas | 75390 | — |
| UT Houston | Houston | Texas | 77030 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Centra Medical Group Neurology Center | Lynchburg | Virginia | 24502 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
| Multi-Care Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03478982, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03478982 live on ClinicalTrials.gov.