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New inhaler aims to halt seizures in seconds

NCT ID NCT05077904

Disease control 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 study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 7 times

Summary

This Phase 3 trial tests a single inhaled dose of alprazolam (a fast-acting sedative) to stop prolonged seizures in people aged 12 and older. The goal is to see if it can end a seizure within 90 seconds and prevent it from coming back for at least 2 hours. About 350 participants will receive either the drug or a placebo inhaler.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alprazolam (inhaled)
What this could lead to
If it works, this could provide a fast-acting, easy-to-use treatment to stop prolonged seizures at home, reducing emergency visits.
What could go wrong
This is still experimental. The trial is testing a single dose, and it may not work better than placebo. Side effects or lack of long-term data are also unknowns.

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 350 people

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

Started

Dec 2021

Expected to finish

Sep 2026

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 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: 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 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: 1. 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 2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: i) 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 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 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) * 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

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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

    126 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Ep0162 20022

    RECRUITING

    Hangzhou, China

  • Ep0162 20025

    RECRUITING

    Wenzhou, China

  • Ep0162 20070

    RECRUITING

    Hachioji-shi, Japan

  • Ep0162 20119

    RECRUITING

    Suzhou, China

  • Ep0162 20123

    WITHDRAWN

    Shanghai, China

  • Ep0162 20124

    RECRUITING

    Guangzhou, China

  • Ep0162 20128

    WITHDRAWN

    Beijing, China

  • Ep0162 20133

    RECRUITING

    Chengdu, China

  • Ep0162 20137

    RECRUITING

    Chengdu, China

  • Ep0162 20143

    RECRUITING

    Kodaira, Japan

  • Ep0162 20147

    RECRUITING

    Kyoto, Japan

  • Ep0162 20179

    RECRUITING

    Fuzhou, China

  • Ep0162 20235

    RECRUITING

    Nagoya, Japan

  • Ep0162 20236

    RECRUITING

    Hōfu, Japan

  • Ep0162 20237

    WITHDRAWN

    Hamamatsu, Japan

  • Ep0162 20238

    RECRUITING

    Niigata, Japan

  • Ep0162 20239

    RECRUITING

    Itami, Japan

  • Ep0162 20240

    RECRUITING

    Shizuoka, Japan

  • Ep0162 20241

    RECRUITING

    Ōmura, Japan

  • Ep0162 20242

    RECRUITING

    Suita, Japan

  • Ep0162 20243

    COMPLETED

    Nagakute, Japan

  • Ep0162 20244

    RECRUITING

    Yamagata, Japan

  • Ep0162 20246

    RECRUITING

    Beijing, China

  • Ep0162 20248

    RECRUITING

    Fukuoka, Japan

  • Ep0162 20249

    RECRUITING

    Hiroshima, Japan

  • Ep0162 20250

    WITHDRAWN

    Chongqing, China

  • Ep0162 20251

    RECRUITING

    Zhengzhou, China

  • Ep0162 20252

    WITHDRAWN

    Wuhan, China

  • Ep0162 20253

    WITHDRAWN

    Nanchang, China

  • Ep0162 20255

    WITHDRAWN

    Yinchuan, China

  • Ep0162 20257

    RECRUITING

    Tianjin, China

  • Ep0162 20258

    RECRUITING

    Lanzhou, China

  • Ep0162 20260

    COMPLETED

    Guangzhou, China

  • Ep0162 20261

    RECRUITING

    Changchun, China

  • Ep0162 20262

    RECRUITING

    Zhanjiang, China

  • Ep0162 20264

    COMPLETED

    Guangzhou, China

  • Ep0162 20266

    RECRUITING

    Tōon, Japan

  • Ep0162 20267

    RECRUITING

    Nanjing, China

  • Ep0162 20268

    COMPLETED

    Beijing, China

  • Ep0162 20269

    RECRUITING

    Guangzhou, China

  • Ep0162 20289

    RECRUITING

    Shijiazhuang, China

  • Ep0162 20292

    RECRUITING

    Shanghai, China

  • Ep0162 20297

    RECRUITING

    Shinjuku-ku, Japan

  • Ep0162 20299

    RECRUITING

    Beijing, China

  • Ep0162 20300

    RECRUITING

    Guangzhou, China

  • Ep0162 20302

    RECRUITING

    Osaka, Japan

  • Ep0162 20315

    RECRUITING

    Koshi-shi, Japan

  • Ep0162 20316

    RECRUITING

    Sapporo, Japan

  • Ep0162 20320

    RECRUITING

    Kunming, China

  • Ep0162 20331

    RECRUITING

    Nanning, China

  • Ep0162 20332

    WITHDRAWN

    Shenzhen, China

  • Ep0162 20333

    RECRUITING

    Qingdao, China

  • Ep0162 20334

    RECRUITING

    Chongqing, China

  • Ep0162 20337

    RECRUITING

    Shimotsuga-gun, Japan

  • Ep0162 30016

    RECRUITING

    Fitzroy, Australia

  • Ep0162 30027

    WITHDRAWN

    Melbourne, Australia

  • Ep0162 30030

    RECRUITING

    Herston, Australia

  • Ep0162 30031

    ACTIVE_NOT_RECRUITING

    South Brisbane, Australia

  • Ep0162 40019

    WITHDRAWN

    Paris, France

  • Ep0162 40023

    RECRUITING

    Erlangen, Germany

  • Ep0162 40063

    COMPLETED

    Prague, Czechia

  • Ep0162 40091

    RECRUITING

    Nowa Sól, Poland

  • Ep0162 40108

    RECRUITING

    Salford, United Kingdom

  • Ep0162 40130

    WITHDRAWN

    Marseille, France

  • Ep0162 40144

    RECRUITING

    Milan, Italy

  • Ep0162 40153

    WITHDRAWN

    Poznan, Poland

  • Ep0162 40157

    RECRUITING

    L'Hospitalet de Llobregat, Spain

  • Ep0162 40160

    RECRUITING

    Barcelona, Spain

  • Ep0162 40163

    RECRUITING

    Oxford, United Kingdom

  • Ep0162 40199

    RECRUITING

    Strasbourg, France

  • Ep0162 40201

    RECRUITING

    Rennes, France

  • Ep0162 40219

    WITHDRAWN

    Krakow, Poland

  • Ep0162 40230

    RECRUITING

    Valencia, Spain

  • Ep0162 40257

    RECRUITING

    Roma, Italy

  • Ep0162 40300

    WITHDRAWN

    Cardiff, United Kingdom

  • Ep0162 40352

    RECRUITING

    Pamplona, Spain

  • Ep0162 40453

    RECRUITING

    Terrassa, Spain

  • Ep0162 40477

    RECRUITING

    Pavia, Italy

  • Ep0162 40502

    COMPLETED

    Krakow, Poland

  • Ep0162 40529

    RECRUITING

    Marburg, Germany

  • Ep0162 40540

    RECRUITING

    Madrid, Spain

  • Ep0162 40577

    WITHDRAWN

    Aachen, Germany

  • Ep0162 40645

    RECRUITING

    Frankfurt am Main, Germany

  • Ep0162 40650

    RECRUITING

    Blagoevgrad, Bulgaria

  • Ep0162 40651

    COMPLETED

    Sofia, Bulgaria

  • Ep0162 40653

    RECRUITING

    Debrecen, Hungary

  • Ep0162 40665

    COMPLETED

    Pleven, Bulgaria

  • Ep0162 40666

    RECRUITING

    Balassagyarmat, Hungary

  • Ep0162 40667

    COMPLETED

    Valladolid, Spain

  • Ep0162 40668

    RECRUITING

    Seville, Spain

  • Ep0162 40670

    RECRUITING

    Brno, Czechia

  • Ep0162 40671

    RECRUITING

    Prague, Czechia

  • Ep0162 40672

    RECRUITING

    Ostrava - Poruba, Czechia

  • Ep0162 40673

    RECRUITING

    Budapest, Hungary

  • Ep0162 40674

    RECRUITING

    Genova, Italy

  • Ep0162 40675

    RECRUITING

    Roma, Italy

  • Ep0162 40676

    COMPLETED

    Lublin, Poland

  • Ep0162 40677

    RECRUITING

    Gdansk, Poland

  • Ep0162 40678

    COMPLETED

    Świdnik, Poland

  • Ep0162 40680

    WITHDRAWN

    Dijon, France

  • Ep0162 40681

    RECRUITING

    Bron, France

  • Ep0162 40682

    RECRUITING

    Paris, France

  • Ep0162 40683

    RECRUITING

    Berlin, Germany

  • Ep0162 40685

    RECRUITING

    Bielefeld, Germany

  • Ep0162 40686

    RECRUITING

    Birmingham, United Kingdom

  • Ep0162 40688

    WITHDRAWN

    Bron, France

  • Ep0162 40689

    COMPLETED

    Kehl-kork, Germany

  • Ep0162 40690

    WITHDRAWN

    Catanzaro, Italy

  • Ep0162 40704

    RECRUITING

    Budapest, Hungary

  • Ep0162 40707

    RECRUITING

    Bydgoszcz, Poland

  • Ep0162 40708

    RECRUITING

    Pazardzhik, Bulgaria

  • Ep0162 40709

    COMPLETED

    Pleven, Bulgaria

  • Ep0162 40714

    RECRUITING

    Prague, Czechia

  • Ep0162 40724

    WITHDRAWN

    München, Germany

  • Ep0162 40735

    RECRUITING

    Glasgow, United Kingdom

  • Ep0162 40833

    RECRUITING

    London, United Kingdom

  • Ep0162 40842

    RECRUITING

    Krakow, Poland

  • Ep0162 50034

    RECRUITING

    Rochester, New York, 14642, United States

  • Ep0162 50047

    COMPLETED

    Boston, Massachusetts, 02215, United States

  • Ep0162 50088

    RECRUITING

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

  • Ep0162 50089

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Ep0162 50093

    WITHDRAWN

    Baltimore, Maryland, 21287, United States

  • Ep0162 50096

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Ep0162 50103

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Ep0162 50110

    COMPLETED

    Ann Arbor, Michigan, 48109, United States

  • Ep0162 50118

    RECRUITING

    Downey, California, 90242, United States

  • Ep0162 50199

    RECRUITING

    Miami, Florida, 33136, United States

  • Ep0162 50298

    RECRUITING

    New York, New York, 10016, United States

  • Ep0162 50299

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Ep0162 50308

    RECRUITING

    Tampa, Florida, 33606, United States

  • Ep0162 50323

    RECRUITING

    Honolulu, Hawaii, 96817, United States

  • Ep0162 50342

    RECRUITING

    Jacksonville, Florida, 32224-1865, United States

  • Ep0162 50364

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Ep0162 50367

    COMPLETED

    New Haven, Connecticut, 06519, United States

  • Ep0162 50371

    WITHDRAWN

    Akron, Ohio, 44308, United States

  • Ep0162 50375

    WITHDRAWN

    Springfield, Illinois, 62702, United States

  • Ep0162 50395

    WITHDRAWN

    New Orleans, Louisiana, 70121, United States

  • Ep0162 50416

    RECRUITING

    La Jolla, California, 92037, United States

  • Ep0162 50473

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Ep0162 50487

    WITHDRAWN

    Charlotte, North Carolina, 28207, United States

  • Ep0162 50488

    WITHDRAWN

    Bethesda, Maryland, 20817, United States

  • Ep0162 50490

    RECRUITING

    New York, New York, 10029, United States

  • Ep0162 50491

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Ep0162 50492

    COMPLETED

    Orange, California, 92868, United States

  • Ep0162 50493

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ep0162 50494

    COMPLETED

    Little Rock, Arkansas, 72205, United States

  • Ep0162 50496

    WITHDRAWN

    Round Rock, Texas, 78681, United States

  • Ep0162 50497

    RECRUITING

    Buffalo, New York, 14221, United States

  • Ep0162 50499

    WITHDRAWN

    Las Vegas, Nevada, 89128, United States

  • Ep0162 50504

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Ep0162 50505

    WITHDRAWN

    Los Angeles, California, 90095, United States

  • Ep0162 50506

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • Ep0162 50507

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Ep0162 50508

    RECRUITING

    Jacksonville, Florida, 32209-6533, United States

  • Ep0162 50509

    COMPLETED

    Orlando, Florida, 32806, United States

  • Ep0162 50510

    WITHDRAWN

    Portland, Oregon, 97239-3098, United States

  • Ep0162 50511

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ep0162 50512

    RECRUITING

    Boise, Idaho, 83702, United States

  • Ep0162 50513

    RECRUITING

    Memphis, Tennessee, 38103-2800, United States

  • Ep0162 50514

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Ep0162 50515

    COMPLETED

    Gulf Breeze, Florida, 32561, United States

  • Ep0162 50517

    RECRUITING

    New Orleans, Louisiana, 70122, United States

  • Ep0162 50518

    RECRUITING

    New York, New York, 10075, United States

  • Ep0162 50525

    RECRUITING

    Houston, Texas, 77459, United States

  • Ep0162 50528

    WITHDRAWN

    Cleveland, Ohio, 44195, United States

  • Ep0162 50561

    WITHDRAWN

    Lexington, Kentucky, 40536, United States

  • Ep0162 50615

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Ep0162 50625

    COMPLETED

    New Hyde Park, New York, 11042, United States

  • Ep0162 50626

    WITHDRAWN

    Neptune City, New Jersey, 07753, United States

  • Ep0162 50676

    RECRUITING

    Miami, Florida, 33176, United States

  • Ep0162 50700

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Ep0162 50701

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ep0162 50702

    RECRUITING

    Long Beach, California, 90806, United States

  • Ep0162 50703

    RECRUITING

    Rockledge, Florida, 32955, United States

  • Ep0162 50714

    RECRUITING

    Houston, Texas, 77030, United States

  • Ep0162 50715

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Ep0162 50716

    RECRUITING

    Sacramento, California, 95817, United States

  • Ep0162 50720

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Ep0162 50721

    WITHDRAWN

    Boca Raton, Florida, 33486, United States

  • Ep0162 50722

    WITHDRAWN

    Poway, California, 92064, United States

  • Ep0162 50724

    COMPLETED

    Portland, Oregon, 97227, United States

  • Ep0162 50726

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Ep0162 50731

    RECRUITING

    Austin, Texas, 78749, United States

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