AzTrials
AzTrials

Stereotypical Prolonged SeizuresPhase 3NCT05077904

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

A Phase 3 study testing Staccato alprazolam in people with Stereotypical Prolonged Seizures, run by UCB Biopharma SRL at 183 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Stereotypical Prolonged Seizures
What is being tested?
Staccato alprazolam
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
183 sitesin 13 countries
Study dates
7 Dec 2021to 29 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participant must be ≥12 years of age at the Baseline/Randomization Visit
  • Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; 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:
  • Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
  • Episodes of a focal seizure with a minimum duration of 3 minutes
  • 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
Show all 15Show fewer
  • Prior to the Screening Visit, participant has experienced ≥4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit
  • Participant has had a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of epilepsy and within the 5 years prior to the Screening Visit, that confirms the absence of a progressive neurological disorder
  • Participant is receiving a regimen of antiseizure medications (ASMs) that has been stable (ie, no addition or removal of ASM[s]; dose adjustments are permitted to ASM[s]; dose adjustments are not permitted for benzodiazepines) for 30 days prior to the Screening Visit
  • Male and female participants:
  • A male participant must agree to use contraception during the Outpatient Treatment Period and for at least 7 days after IMP administration and refrain from donating sperm during this period
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the Outpatient Treatment Period and for at least 30 days after IMP administration
  • Participant is capable of giving signed informed consent (or giving assent, where required), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), the protocol, and the individualized participant management plan (iPMP). The ICF or a specific assent form, where required, will be signed and dated by minors
  • The participant's study caregiver(s) must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF, the protocol, and the iPMP

Who cannot join

  • 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 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 diagnosis of atrial fibrillation or mitral stenosis
  • 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)
Show all 25Show fewer
  • 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 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 upper respiratory tract infection within 4 weeks or 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 (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)
  • Participant has a history or presence of long QT syndrome, a family history of sudden death due to long QT syndrome, or unexplained syncope
  • Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be allowed for approximately 30 % of study participants
  • 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 (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis
  • Participant is taking nonselective beta blockers on a chronic basis
  • Participant is taking pharmacotherapy for an active major psychiatric disorder where major changes in regimen are needed or anticipated during the study
  • Participant has been treated with vagal nerve stimulation (VNS) for less than 6 months or VNS settings have changed within 30 days before the Screening Visit
  • Participant has a clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, according to the judgment of the Investigator
  • Participant has an oxygen saturation <95 % (or less than normal in regions of altitude >2500 meters) for greater than 30 seconds during the Screening Visit. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will be excluded
  • Participant has >2.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome or >2.0xULN total bilirubin for liver impairment)
  • Participant has current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis
  • Participant has a QT interval corrected for heart rate (QTc) >450 msec (males), QTc interval >470 msec (females), or QTc interval >480 msec (participants with bundle branch block), PR interval ≥220 msec, or any other clinically significant electrocardiogram (ECG) abnormality according to the Investigator i) The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF). It is either machine-read or manually over-read
  • Participant has a positive urine screen for drugs of abuse at the Screening Visit
  • Participant has a blood pressure (BP) or heart rate (HR) outside the following range after 5 minutes rest: systolic BP: 90 mmHg to 150 mmHg; diastolic BP: 4 0mmHg to 95 mmHg; HR: 50 bpm to 100 bpm. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will be excluded

Trial locations and contacts

183 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

UCB Cares contact

1-844-599-2273 (USA)

UCBCares@ucb.com

UCB Cares contact

0018445992273

UCBCares@ucb.com

183 sites in 13 countries

United States66 sites, 42 recruiting

  • Ep0162 50371

    Akron, Ohio, 44308

    Withdrawn

  • Ep0162 50110

    Ann Arbor, Michigan, 48109

    Completed

  • Ep0162 50731

    Austin, Texas, 78749

    Recruiting

  • Ep0162 50093

    Baltimore, Maryland, 21287

    Withdrawn

  • Ep0162 50488

    Bethesda, Maryland, 20817

    Withdrawn

  • Ep0162 50721

    Boca Raton, Florida, 33486

    Withdrawn

  • Ep0162 50512

    Boise, Idaho, 83702

    Recruiting

  • Ep0162 50615

    Boston, Massachusetts, 02118

    Recruiting

  • Ep0162 50047

    Boston, Massachusetts, 02215

    Completed

  • Ep0162 50497

    Buffalo, New York, 14221

    Recruiting

  • Ep0162 50514

    Charlotte, North Carolina, 28204

    Recruiting

  • Ep0162 50487

    Charlotte, North Carolina, 28207

    Withdrawn

  • Ep0162 50700

    Chattanooga, Tennessee, 37403

    Recruiting

  • Ep0162 50493

    Chicago, Illinois, 60611

    Recruiting

  • Ep0162 50528

    Cleveland, Ohio, 44195

    Withdrawn

  • Ep0162 50118

    Downey, California, 90242

    Recruiting

  • Ep0162 50715

    Durham, North Carolina, 27705

    Recruiting

  • Ep0162 50504

    Fort Wayne, Indiana, 46804

    Recruiting

  • Ep0162 50515

    Gulf Breeze, Florida, 32561

    Completed

  • Ep0162 50323

    Honolulu, Hawaii, 96817

    Recruiting

  • Ep0162 50714

    Houston, Texas, 77030

    Recruiting

  • Ep0162 50525

    Houston, Texas, 77459

    Recruiting

  • Ep0162 50508

    Jacksonville, Florida, 32209-6533

    Recruiting

  • Ep0162 50342

    Jacksonville, Florida, 32224-1865

    Recruiting

  • Ep0162 50416

    La Jolla, California, 92037

    Recruiting

  • Ep0162 50499

    Las Vegas, Nevada, 89128

    Withdrawn

  • Ep0162 50561

    Lexington, Kentucky, 40536

    Withdrawn

  • Ep0162 50494

    Little Rock, Arkansas, 72205

    Completed

  • Ep0162 50702

    Long Beach, California, 90806

    Recruiting

  • Ep0162 50505

    Los Angeles, California, 90095

    Withdrawn

  • Ep0162 50513

    Memphis, Tennessee, 38103-2800

    Recruiting

  • Ep0162 50199

    Miami, Florida, 33136

    Recruiting

  • Ep0162 50676

    Miami, Florida, 33176

    Recruiting

  • Ep0162 50103

    Nashville, Tennessee, 37232

    Recruiting

  • Ep0162 50626

    Neptune City, New Jersey, 07753

    Withdrawn

  • Ep0162 50299

    New Brunswick, New Jersey, 08901

    Recruiting

  • Ep0162 50367

    New Haven, Connecticut, 06519

    Completed

  • Ep0162 50625

    New Hyde Park, New York, 11042

    Completed

  • Ep0162 50395

    New Orleans, Louisiana, 70121

    Withdrawn

  • Ep0162 50517

    New Orleans, Louisiana, 70122

    Recruiting

  • Ep0162 50298

    New York, New York, 10016

    Recruiting

  • Ep0162 50490

    New York, New York, 10029

    Recruiting

  • Ep0162 50518

    New York, New York, 10075

    Recruiting

  • Ep0162 50492

    Orange, California, 92868

    Completed

  • Ep0162 50509

    Orlando, Florida, 32806

    Completed

  • Ep0162 50096

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Ep0162 50364

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Ep0162 50089

    Philadelphia, Pennsylvania, 19140

    Recruiting

  • Ep0162 50506

    Phoenix, Arizona, 85004

    Recruiting

  • Ep0162 50511

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • Ep0162 50491

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Ep0162 50724

    Portland, Oregon, 97227

    Completed

  • Ep0162 50510

    Portland, Oregon, 97239-3098

    Withdrawn

  • Ep0162 50701

    Portland, Oregon, 97239

    Recruiting

  • Ep0162 50722

    Poway, California, 92064

    Withdrawn

  • Ep0162 50034

    Rochester, New York, 14642

    Recruiting

  • Ep0162 50703

    Rockledge, Florida, 32955

    Recruiting

  • Ep0162 50496

    Round Rock, Texas, 78681

    Withdrawn

  • Ep0162 50716

    Sacramento, California, 95817

    Recruiting

  • Ep0162 50473

    Salt Lake City, Utah, 84132

    Recruiting

  • Ep0162 50720

    Scottsdale, Arizona, 85253

    Recruiting

  • Ep0162 50375

    Springfield, Illinois, 62702

    Withdrawn

  • Ep0162 50507

    St Louis, Missouri, 63110

    Recruiting

  • Ep0162 50308

    Tampa, Florida, 33606

    Recruiting

  • Ep0162 50088

    Washington D.C., District of Columbia, 20037

    Recruiting

  • Ep0162 50726

    Winchester, Virginia, 22601

    Recruiting

Other trials in United States

China33 sites, 23 recruiting

  • Ep0162 20128

    Beijing

    Withdrawn

  • Ep0162 20246

    Beijing

    Recruiting

  • Ep0162 20268

    Beijing

    Completed

  • Ep0162 20299

    Beijing

    Recruiting

  • Ep0162 20261

    Changchun

    Recruiting

  • Ep0162 20133

    Chengdu

    Recruiting

  • Ep0162 20137

    Chengdu

    Recruiting

  • Ep0162 20250

    Chongqing

    Withdrawn

  • Ep0162 20334

    Chongqing

    Recruiting

  • Ep0162 20179

    Fuzhou

    Recruiting

  • Ep0162 20124

    Guangzhou

    Recruiting

  • Ep0162 20260

    Guangzhou

    Completed

  • Ep0162 20264

    Guangzhou

    Completed

  • Ep0162 20269

    Guangzhou

    Recruiting

  • Ep0162 20300

    Guangzhou

    Recruiting

  • Ep0162 20022

    Hangzhou

    Recruiting

  • Ep0162 20320

    Kunming

    Recruiting

  • Ep0162 20258

    Lanzhou

    Recruiting

  • Ep0162 20253

    Nanchang

    Withdrawn

  • Ep0162 20267

    Nanjing

    Recruiting

  • Ep0162 20331

    Nanning

    Recruiting

  • Ep0162 20333

    Qingdao

    Recruiting

  • Ep0162 20123

    Shanghai

    Withdrawn

  • Ep0162 20292

    Shanghai

    Recruiting

  • Ep0162 20332

    Shenzhen

    Withdrawn

  • Ep0162 20289

    Shijiazhuang

    Recruiting

  • Ep0162 20119

    Suzhou

    Recruiting

  • Ep0162 20257

    Tianjin

    Recruiting

  • Ep0162 20025

    Wenzhou

    Recruiting

  • Ep0162 20252

    Wuhan

    Withdrawn

  • Ep0162 20255

    Yinchuan

    Withdrawn

  • Ep0162 20262

    Zhanjiang

    Recruiting

  • Ep0162 20251

    Zhengzhou

    Recruiting

Other trials in China

Japan21 sites, 19 recruiting

  • Ep0162 20248

    Fukuoka

    Recruiting

  • Ep0162 20070

    Hachioji-shi

    Recruiting

  • Ep0162 20237

    Hamamatsu

    Withdrawn

  • Ep0162 20249

    Hiroshima

    Recruiting

  • Ep0162 20236

    Hōfu

    Recruiting

  • Ep0162 20239

    Itami

    Recruiting

  • Ep0162 20143

    Kodaira

    Recruiting

  • Ep0162 20315

    Koshi-shi

    Recruiting

  • Ep0162 20147

    Kyoto

    Recruiting

  • Ep0162 20243

    Nagakute

    Completed

  • Ep0162 20235

    Nagoya

    Recruiting

  • Ep0162 20238

    Niigata

    Recruiting

  • Ep0162 20241

    Ōmura

    Recruiting

  • Ep0162 20302

    Osaka

    Recruiting

  • Ep0162 20316

    Sapporo

    Recruiting

  • Ep0162 20337

    Shimotsuga-gun

    Recruiting

  • Ep0162 20297

    Shinjuku-ku

    Recruiting

  • Ep0162 20240

    Shizuoka

    Recruiting

  • Ep0162 20242

    Suita

    Recruiting

  • Ep0162 20266

    Tōon

    Recruiting

  • Ep0162 20244

    Yamagata

    Recruiting

Other trials in Japan

Poland9 sites, 4 recruiting

  • Ep0162 40707

    Bydgoszcz

    Recruiting

  • Ep0162 40677

    Gdansk

    Recruiting

  • Ep0162 40219

    Krakow

    Withdrawn

  • Ep0162 40502

    Krakow

    Completed

  • Ep0162 40842

    Krakow

    Recruiting

  • Ep0162 40676

    Lublin

    Completed

  • Ep0162 40091

    Nowa Sól

    Recruiting

  • Ep0162 40153

    Poznan

    Withdrawn

  • Ep0162 40678

    Świdnik

    Completed

Other trials in Poland

France8 sites, 4 recruiting

  • Ep0162 40681

    Bron

    Recruiting

  • Ep0162 40688

    Bron

    Withdrawn

  • Ep0162 40680

    Dijon

    Withdrawn

  • Ep0162 40130

    Marseille

    Withdrawn

  • Ep0162 40019

    Paris

    Withdrawn

  • Ep0162 40682

    Paris

    Recruiting

  • Ep0162 40201

    Rennes

    Recruiting

  • Ep0162 40199

    Strasbourg

    Recruiting

Other trials in France

Germany8 sites, 5 recruiting

  • Ep0162 40577

    Aachen

    Withdrawn

  • Ep0162 40683

    Berlin

    Recruiting

  • Ep0162 40685

    Bielefeld

    Recruiting

  • Ep0162 40023

    Erlangen

    Recruiting

  • Ep0162 40645

    Frankfurt am Main

    Recruiting

  • Ep0162 40689

    Kehl-kork

    Completed

  • Ep0162 40529

    Marburg

    Recruiting

  • Ep0162 40724

    München

    Withdrawn

Other trials in Germany

Spain8 sites, 7 recruiting

  • Ep0162 40160

    Barcelona

    Recruiting

  • Ep0162 40157

    L'Hospitalet de Llobregat

    Recruiting

  • Ep0162 40540

    Madrid

    Recruiting

  • Ep0162 40352

    Pamplona

    Recruiting

  • Ep0162 40668

    Seville

    Recruiting

  • Ep0162 40453

    Terrassa

    Recruiting

  • Ep0162 40230

    Valencia

    Recruiting

  • Ep0162 40667

    Valladolid

    Completed

Other trials in Spain

Italy6 sites, 4 recruiting

  • Ep0162 40690

    Catanzaro

    Withdrawn

  • Ep0162 40674

    Genova

    Recruiting

  • Ep0162 40144

    Milan

    Recruiting

  • Ep0162 40477

    Pavia

    Recruiting

  • Ep0162 40257

    Roma

    Recruiting

  • Ep0162 40675

    Roma

    Completed

Other trials in Italy

United Kingdom6 sites, 5 recruiting

  • Ep0162 40686

    Birmingham

    Recruiting

  • Ep0162 40300

    Cardiff

    Withdrawn

  • Ep0162 40735

    Glasgow

    Recruiting

  • Ep0162 40833

    London

    Recruiting

  • Ep0162 40163

    Oxford

    Recruiting

  • Ep0162 40108

    Salford

    Recruiting

Other trials in United Kingdom

Bulgaria5 sites, 2 recruiting

  • Ep0162 40650

    Blagoevgrad

    Recruiting

  • Ep0162 40708

    Pazardzhik

    Recruiting

  • Ep0162 40665

    Pleven

    Completed

  • Ep0162 40709

    Pleven

    Completed

  • Ep0162 40651

    Sofia

    Completed

Other trials in Bulgaria

Czechia5 sites, 4 recruiting

  • Ep0162 40670

    Brno

    Recruiting

  • Ep0162 40672

    Ostrava - Poruba

    Recruiting

  • Ep0162 40063

    Prague

    Completed

  • Ep0162 40671

    Prague

    Recruiting

  • Ep0162 40714

    Prague

    Recruiting

Other trials in Czechia

Australia4 sites, 2 recruiting

  • Ep0162 30016

    Fitzroy

    Recruiting

  • Ep0162 30030

    Herston

    Recruiting

  • Ep0162 30027

    Melbourne

    Withdrawn

  • Ep0162 30031

    South Brisbane

    Active, not recruiting

Other trials in Australia

Hungary4 sites, 4 recruiting

  • Ep0162 40666

    Balassagyarmat

    Recruiting

  • Ep0162 40673

    Budapest

    Recruiting

  • Ep0162 40704

    Budapest

    Recruiting

  • Ep0162 40653

    Debrecen

    Recruiting

Other trials in Hungary

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

Being tested
Staccato alprazolam, Placebo
Keywords
Stereotypical prolonged seizures, Phase 3, Staccato alprazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staccato alprazolamDrug

    Also called UCB7538

    Route of administration: Inhalation

    Participants will receive one dose of Staccato alprazolam during the Treatment Period.

  • PlaceboOther

    Route of administration: Inhalation

    Participants will receive one dose of placebo during the Treatment Period.

Study groups in NCT05077904
Study groupRoleWhat they receive
Staccato alprazolam ArmExperimentalParticipants randomized to this arm will receive a single dose of Staccato alprazolam by inhalation.
Receives: Drug: Staccato alprazolam
Placebo ArmPlacebo comparatorParticipants randomized to this arm will receive a single dose of placebo by inhalation.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration

    Treatment success for the treated seizure is defined as termination of the seizure within 90 seconds after IMP administration.

    Measured: From start of IMP treatment through 6 hours

  2. Treatment success for the treated seizure with no recurrence up to 2 hours

    Treatment success for the treated seizure is defined as termination of the treated seizure within 90 seconds after IMP administration and no recurrence of seizure(s) from IMP administration to 2 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 2 hours after IMP administration.

    Measured: From start of IMP treatment through 2 hours

Secondary outcomes (6)

  1. Treatment success for treated seizure with no recurrence after 4 hours

    Treatment success defined as termination of the treated seizure within 90 seconds after IMP administration, with no recurrence of seizure(s) up to 4 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 4 hours after IMP administration.

    Measured: From start of IMP treatment through 4 hours

  2. Treatment success for treated seizure with no recurrence after 6 hours

    Treatment success defined as termination of the treated seizure within 90 seconds after IMP administration, with no recurrence of seizure(s) up to 6 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 6 hours after IMP administration.

    Measured: From start of IMP treatment through 6 hours

  3. Time from IMP administration to cessation of the treated seizure

    The time will be assessed from IMP administration to cessation of the treated seizure (taking administration of seizure rescue treatment as censoring point).

    Measured: From start of IMP treatment through 6 hours

  4. Frequency of respiratory treatment emergent adverse events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.

    Measured: From start of IMP treatment up to the Safety Follow-up Visit (Week 19)

  5. Number of subsequent seizure(s) up to 2 hours after IMP administration

    The number of subsequent seizure(s) will be assessed up to 2 hours after IMP administration.

    Measured: From start of IMP treatment through 2 hours

  6. Time to first subsequent seizure up to 2 hours after IMP administration

    The time to first subsequent seizure will be assessed up to 2 hours after IMP administration and is defined as time from end of IMP treated seizure to start of first subsequent seizure.

    Measured: From start of IMP treatment through 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start7 Dec 2021
  3. Primary completion29 Mar 2027 (estimated)
  4. Study completion29 Mar 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077904
Sponsor's protocol ID
EP0162
Other IDs
2021-002686-18, U1111-1303-2588, 2024-510950-29
Status last verified
Nov 2026
First submitted
30 Sep 2021
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
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 reidentifying 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Staccato alprazolam in people with Stereotypical Prolonged Seizures, run by UCB Biopharma SRL at 183 sites in 13 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 15 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, China, Japan, Poland, France and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact UCB Cares (1-844-599-2273 (USA), UCBCares@ucb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration (time frame: From start of IMP treatment through 6 hours). The study lists 2 primary outcomes in all. 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 NCT05077904.

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 6 Nov 2026.

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