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New inhaler aims to stop prolonged seizures fast and safely

NCT ID NCT05076617

Symptom relief Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests the long-term safety of an inhaled medication called Staccato alprazolam for people aged 12 and older who have prolonged seizures. About 300 participants will use the inhaler when a seizure starts to see if it stops the seizure quickly and without serious side effects. The goal is to provide a fast-acting, easy-to-use treatment option for seizure emergencies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307)) 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 (generalized tonic-clonic) 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 (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation). NOTE: Participants with mild asthma who qualify for inclusion in the are allowed to be enrolled even though they have known airway hypersensitivity * Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases \[including idiopathic pulmonary fibrosis\]) and/or recent history or presence of hemoptysis or pneumothorax * 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 as per the regional labeling * 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

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stereotypical prolonged seizures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    137 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ep0165 20022

    Hangzhou, China

  • Ep0165 20025

    Wenzhou, China

  • Ep0165 20070

    Hachioji-shi, Japan

  • Ep0165 20119

    Suzhou, China

  • Ep0165 20124

    Guangzhou, China

  • Ep0165 20133

    Chengdu, China

  • Ep0165 20137

    Chengdu, China

  • Ep0165 20143

    Kodaira, Japan

  • Ep0165 20147

    Kyoto, Japan

  • Ep0165 20179

    Fuzhou, China

  • Ep0165 20236

    Hōfu, Japan

  • Ep0165 20238

    Niigata, Japan

  • Ep0165 20239

    Itami, Japan

  • Ep0165 20240

    Shizuoka, Japan

  • Ep0165 20241

    Ōmura, Japan

  • Ep0165 20242

    Suita, Japan

  • Ep0165 20244

    Yamagata, Japan

  • Ep0165 20246

    Beijing, China

  • Ep0165 20248

    Fukuoka, Japan

  • Ep0165 20249

    Hiroshima, Japan

  • Ep0165 20251

    Zhengzhou, China

  • Ep0165 20257

    Tianjin, China

  • Ep0165 20258

    Lanzhou, China

  • Ep0165 20261

    Changchun, China

  • Ep0165 20262

    Zhanjiang, China

  • Ep0165 20264

    Guangzhou, China

  • Ep0165 20266

    Tōon, Japan

  • Ep0165 20267

    Nanjing, China

  • Ep0165 20268

    Beijing, China

  • Ep0165 20269

    Guangzhou, China

  • Ep0165 20289

    Shijiazhuang, China

  • Ep0165 20292

    Shanghai, China

  • Ep0165 20297

    Shinjuku-ku, Japan

  • Ep0165 20299

    Beijing, China

  • Ep0165 20300

    Guangzhou, China

  • Ep0165 20302

    Osaka, Japan

  • Ep0165 20315

    Koshi-shi, Japan

  • Ep0165 20316

    Sapporo, Japan

  • Ep0165 20320

    Kunming, China

  • Ep0165 20331

    Nanning, China

  • Ep0165 20333

    Qingdao, China

  • Ep0165 20334

    Chongqing, China

  • Ep0165 20337

    Shimotsuga-gun, Japan

  • Ep0165 30016

    Fitzroy, Australia

  • Ep0165 30030

    Herston, Australia

  • Ep0165 30031

    South Brisbane, Australia

  • Ep0165 40023

    Erlangen, Germany

  • Ep0165 40063

    Prague, Czechia

  • Ep0165 40091

    Nowa Sól, Poland

  • Ep0165 40108

    Salford, United Kingdom

  • Ep0165 40144

    Milan, Italy

  • Ep0165 40157

    L'Hospitalet de Llobregat, Spain

  • Ep0165 40160

    Barcelona, Spain

  • Ep0165 40163

    Oxford, United Kingdom

  • Ep0165 40230

    Valencia, Spain

  • Ep0165 40257

    Roma, Italy

  • Ep0165 40352

    Pamplona, Spain

  • Ep0165 40453

    Terrassa, Spain

  • Ep0165 40477

    Pavia, Italy

  • Ep0165 40529

    Marburg, Germany

  • Ep0165 40540

    Madrid, Spain

  • Ep0165 40645

    Frankfurt am Main, Germany

  • Ep0165 40650

    Blagoevgrad, Bulgaria

  • Ep0165 40651

    Sofia, Bulgaria

  • Ep0165 40653

    Debrecen, Hungary

  • Ep0165 40665

    Pleven, Bulgaria

  • Ep0165 40666

    Balassagyarmat, Hungary

  • Ep0165 40667

    Valladolid, Spain

  • Ep0165 40668

    Seville, Spain

  • Ep0165 40670

    Brno, Czechia

  • Ep0165 40671

    Prague, Czechia

  • Ep0165 40672

    Ostrava - Poruba, Czechia

  • Ep0165 40673

    Budapest, Hungary

  • Ep0165 40674

    Genova, Italy

  • Ep0165 40675

    Roma, Italy

  • Ep0165 40676

    Lublin, Poland

  • Ep0165 40677

    Gdansk, Poland

  • Ep0165 40678

    Świdnik, Poland

  • Ep0165 40683

    Berlin, Germany

  • Ep0165 40685

    Bielefeld, Germany

  • Ep0165 40686

    Birmingham, United Kingdom

  • Ep0165 40689

    Kehl, Germany

  • Ep0165 40704

    Budapest, Hungary

  • Ep0165 40707

    Bydgoszcz, Poland

  • Ep0165 40708

    Pazardzhik, Bulgaria

  • Ep0165 40714

    Prague, Czechia

  • Ep0165 40735

    Glasgow, United Kingdom

  • Ep0165 40833

    London, United Kingdom

  • Ep0165 40842

    Krakow, Poland

  • Ep0165 50034

    Rochester, New York, 14642, United States

  • Ep0165 50047

    Boston, Massachusetts, 02215, United States

  • Ep0165 50088

    Washington D.C., District of Columbia, 20037, United States

  • Ep0165 50089

    Philadelphia, Pennsylvania, 19140, United States

  • Ep0165 50096

    Philadelphia, Pennsylvania, 19104, United States

  • Ep0165 50103

    Nashville, Tennessee, 37232, United States

  • Ep0165 50118

    Downey, California, 90242, United States

  • Ep0165 50199

    Miami, Florida, 33136, United States

  • Ep0165 50298

    New York, New York, 10016, United States

  • Ep0165 50299

    New Brunswick, New Jersey, 08901, United States

  • Ep0165 50308

    Tampa, Florida, 33606, United States

  • Ep0165 50323

    Honolulu, Hawaii, 96817, United States

  • Ep0165 50342

    Jacksonville, Florida, 32224, United States

  • Ep0165 50364

    Philadelphia, Pennsylvania, 19107, United States

  • Ep0165 50416

    La Jolla, California, 92037, United States

  • Ep0165 50473

    Salt Lake City, Utah, 84132, United States

  • Ep0165 50490

    New York, New York, 10029, United States

  • Ep0165 50491

    Pittsburgh, Pennsylvania, 15213, United States

  • Ep0165 50493

    Chicago, Illinois, 60611, United States

  • Ep0165 50494

    Little Rock, Arkansas, 72205, United States

  • Ep0165 50497

    Amherst, New York, 14226, United States

  • Ep0165 50504

    Fort Wayne, Indiana, 46845, United States

  • Ep0165 50506

    Phoenix, Arizona, 85004, United States

  • Ep0165 50507

    St Louis, Missouri, 63110, United States

  • Ep0165 50508

    Jacksonville, Florida, 32209-6533, United States

  • Ep0165 50509

    Orlando, Florida, 32806, United States

  • Ep0165 50511

    Pittsburgh, Pennsylvania, 15212, United States

  • Ep0165 50512

    Boise, Idaho, 83702, United States

  • Ep0165 50513

    Memphis, Tennessee, 38103-2800, United States

  • Ep0165 50514

    Charlotte, North Carolina, 28204, United States

  • Ep0165 50515

    Gulf Breeze, Florida, 32561, United States

  • Ep0165 50517

    New Orleans, Louisiana, 70122, United States

  • Ep0165 50518

    New York, New York, 10075, United States

  • Ep0165 50525

    Houston, Texas, 77459, United States

  • Ep0165 50615

    Boston, Massachusetts, 02118, United States

  • Ep0165 50625

    New Hyde Park, New York, 11042, United States

  • Ep0165 50676

    Miami, Florida, 33176, United States

  • Ep0165 50700

    Chattanooga, Tennessee, 37403, United States

  • Ep0165 50701

    Portland, Oregon, 97239, United States

  • Ep0165 50702

    Long Beach, California, 90806, United States

  • Ep0165 50703

    Rockledge, Florida, 32955, United States

  • Ep0165 50714

    Houston, Texas, 77030, United States

  • Ep0165 50715

    Durham, North Carolina, 27705, United States

  • Ep0165 50716

    Sacramento, California, 95817, United States

  • Ep0165 50720

    Scottsdale, Arizona, 85253, United States

  • Ep0165 50722

    Poway, California, 92064, United States

  • Ep0165 50726

    Winchester, Virginia, 22601, United States

  • Ep0165 50731

    Austin, Texas, 78749, United States

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