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ENROLLING BY INVITATION

NCT05076617

PHASE3

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

Official title: An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2022-02-03

Completion Date

2028-11-30

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Stereotypical Prolonged Seizures

Interventions

DRUG

Staccato alprazolam

* Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period.

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

Locations (145)

Ep0165 50506

Phoenix, Arizona, United States

Ep0165 50720

Scottsdale, Arizona, United States

Ep0165 50494

Little Rock, Arkansas, United States

Ep0165 50118

Downey, California, United States

Ep0165 50416

La Jolla, California, United States

Ep0165 50702

Long Beach, California, United States

Ep0165 50722

Poway, California, United States

Ep0165 50716

Sacramento, California, United States

Ep0165 50367

New Haven, Connecticut, United States

Ep0165 50088

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

Ep0165 50721

Boca Raton, Florida, United States

Ep0165 50515

Gulf Breeze, Florida, United States

Ep0165 50508

Jacksonville, Florida, United States

Ep0165 50342

Jacksonville, Florida, United States

Ep0165 50199

Miami, Florida, United States

Ep0165 50676

Miami, Florida, United States

Ep0165 50509

Orlando, Florida, United States

Ep0165 50703

Rockledge, Florida, United States

Ep0165 50308

Tampa, Florida, United States

Ep0165 50323

Honolulu, Hawaii, United States

Ep0165 50512

Boise, Idaho, United States

Ep0165 50493

Chicago, Illinois, United States

Ep0165 50375

Springfield, Illinois, United States

Ep0165 50504

Fort Wayne, Indiana, United States

Ep0165 50517

New Orleans, Louisiana, United States

Ep0165 50615

Boston, Massachusetts, United States

Ep0165 50047

Boston, Massachusetts, United States

Ep0165 50507

St Louis, Missouri, United States

Ep0165 50626

Neptune City, New Jersey, United States

Ep0165 50299

New Brunswick, New Jersey, United States

Ep0165 50497

Amherst, New York, United States

Ep0165 50625

New Hyde Park, New York, United States

Ep0165 50298

New York, New York, United States

Ep0165 50490

New York, New York, United States

Ep0165 50518

New York, New York, United States

Ep0165 50034

Rochester, New York, United States

Ep0165 50514

Charlotte, North Carolina, United States

Ep0165 50715

Durham, North Carolina, United States

Ep0165 50724

Portland, Oregon, United States

Ep0165 50096

Philadelphia, Pennsylvania, United States

Ep0165 50364

Philadelphia, Pennsylvania, United States

Ep0165 50089

Philadelphia, Pennsylvania, United States

Ep0165 50511

Pittsburgh, Pennsylvania, United States

Ep0165 50491

Pittsburgh, Pennsylvania, United States

Ep0165 50700

Chattanooga, Tennessee, United States

Ep0165 50513

Memphis, Tennessee, United States

Ep0165 50103

Nashville, Tennessee, United States

Ep0165 50731

Austin, Texas, United States

Ep0165 50714

Houston, Texas, United States

Ep0165 50525

Houston, Texas, United States

Ep0165 50473

Salt Lake City, Utah, United States

Ep0165 50726

Winchester, Virginia, United States

Ep0165 30016

Fitzroy, Australia

Ep0165 30030

Herston, Australia

Ep0165 30031

South Brisbane, Australia

Ep0165 40650

Blagoevgrad, Bulgaria

Ep0165 40708

Pazardzhik, Bulgaria

Ep0165 40665

Pleven, Bulgaria

Ep0165 40709

Pleven, Bulgaria

Ep0165 40651

Sofia, Bulgaria

Ep0165 20246

Beijing, China

Ep0165 20268

Beijing, China

Ep0165 20299

Beijing, China

Ep0165 20261

Changchun, China

Ep0165 20133

Chengdu, China

Ep0165 20137

Chengdu, China

Ep0165 20334

Chongqing, China

Ep0165 20179

Fuzhou, China

Ep0165 20124

Guangzhou, China

Ep0165 20264

Guangzhou, China

Ep0165 20269

Guangzhou, China

Ep0165 20300

Guangzhou, China

Ep0165 20022

Hangzhou, China

Ep0165 20320

Kunming, China

Ep0165 20258

Lanzhou, China

Ep0165 20267

Nanjing, China

Ep0165 20331

Nanning, China

Ep0165 20333

Qingdao, China

Ep0165 20292

Shanghai, China

Ep0165 20289

Shijiazhuang, China

Ep0165 20119

Suzhou, China

Ep0165 20257

Tianjin, China

Ep0165 20025

Wenzhou, China

Ep0165 20262

Zhanjiang, China

Ep0165 20251

Zhengzhou, China

Ep0165 40670

Brno, Czechia

Ep0165 40672

Ostrava - Poruba, Czechia

Ep0165 40063

Prague, Czechia

Ep0165 40671

Prague, Czechia

Ep0165 40714

Prague, Czechia

Ep0165 40683

Berlin, Germany

Ep0165 40685

Bielefeld, Germany

Ep0165 40023

Erlangen, Germany

Ep0165 40645

Frankfurt am Main, Germany

Ep0165 40689

Kehl, Germany

Ep0165 40529

Marburg, Germany

Ep0165 40724

München, Germany

Ep0165 40666

Balassagyarmat, Hungary

Ep0165 40673

Budapest, Hungary

Ep0165 40704

Budapest, Hungary

Ep0165 40653

Debrecen, Hungary

Ep0165 40674

Genova, Italy

Ep0165 40144

Milan, Italy

Ep0165 40477

Pavia, Italy

Ep0165 40257

Roma, Italy

Ep0165 40675

Roma, Italy

Ep0165 20248

Fukuoka, Japan

Ep0165 20070

Hachioji-shi, Japan

Ep0165 20249

Hiroshima, Japan

Ep0165 20236

Hōfu, Japan

Ep0165 20239

Itami, Japan

Ep0165 20143

Kodaira, Japan

Ep0165 20315

Koshi-shi, Japan

Ep0165 20147

Kyoto, Japan

Ep0165 20243

Nagakute, Japan

Ep0165 20238

Niigata, Japan

Ep0165 20302

Osaka, Japan

Ep0165 20241

Ōmura, Japan

Ep0165 20316

Sapporo, Japan

Ep0165 20337

Shimotsuga-gun, Japan

Ep0165 20297

Shinjuku-ku, Japan

Ep0165 20240

Shizuoka, Japan

Ep0165 20242

Suita, Japan

Ep0165 20266

Tōon, Japan

Ep0165 20244

Yamagata, Japan

Ep0165 40707

Bydgoszcz, Poland

Ep0165 40677

Gdansk, Poland

Ep0165 40502

Krakow, Poland

Ep0165 40842

Krakow, Poland

Ep0165 40676

Lublin, Poland

Ep0165 40091

Nowa Sól, Poland

Ep0165 40678

Świdnik, Poland

Ep0165 40160

Barcelona, Spain

Ep0165 40157

L'Hospitalet de Llobregat, Spain

Ep0165 40540

Madrid, Spain

Ep0165 40352

Pamplona, Spain

Ep0165 40668

Seville, Spain

Ep0165 40453

Terrassa, Spain

Ep0165 40230

Valencia, Spain

Ep0165 40667

Valladolid, Spain

Ep0165 40686

Birmingham, United Kingdom

Ep0165 40735

Glasgow, United Kingdom

Ep0165 40833

London, United Kingdom

Ep0165 40163

Oxford, United Kingdom

Ep0165 40108

Salford, United Kingdom

Clinical Research Directory

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (145)