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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Staccato alprazolam Arm 		Participants randomized to this arm will receive a single dose of Staccato alprazolam by inhalation.
  • Drug: Staccato alprazolam
    Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
    Other names:
    • UCB7538
Placebo Comparator
Placebo Arm 		Participants randomized to this arm will receive a single dose of placebo by inhalation.
  • Other: Placebo
    Route of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.

Recruiting Locations

Ep0162 50506
Phoenix, Arizona 85004

Ep0162 50720
Scottsdale, Arizona 85254

Ep0162 50494
Little Rock, Arkansas 72205

Ep0162 50118
Downey, California 90242

Ep0162 50416
La Jolla, California 92037

Ep0162 50702
Long Beach, California 90806

Ep0162 50722
Poway, California 92064

Ep0162 50716
Sacramento, California 95817

Ep0162 50088
Washington D.C., District of Columbia 20037

Ep0162 50721
Boca Raton, Florida 33486

Ep0162 50515
Gulf Breeze, Florida 32561

Ep0162 50508
Jacksonville, Florida 32209-6533

Ep0162 50342
Jacksonville, Florida 32224-1865

Ep0162 50199
Miami, Florida 33136

Ep0162 50676
Miami, Florida 33176

Ep0162 50703
Rockledge, Florida 32955

Ep0162 50308
Tampa, Florida 33606

Ep0162 50323
Honolulu, Hawaii 96817

Ep0162 50512
Boise, Idaho 83702

Ep0162 50493
Chicago, Illinois 60611

Ep0162 50375
Springfield, Illinois 62702

Ep0162 50504
Fort Wayne, Indiana 46804

Ep0162 50517
New Orleans, Louisiana 70122

Ep0162 50615
Boston, Massachusetts 02118

Ep0162 50047
Boston, Massachusetts 02215

Ep0162 50507
St Louis, Missouri 63110

Ep0162 50626
Neptune City, New Jersey 07753

Ep0162 50299
New Brunswick, New Jersey 08901

Ep0162 50497
Buffalo, New York 14221

Ep0162 50625
New Hyde Park, New York 11042

Ep0162 50298
New York, New York 10016

Ep0162 50490
New York, New York 10029

Ep0162 50518
New York, New York 10075

Ep0162 50034
Rochester, New York 14642

Ep0162 50514
Charlotte, North Carolina 28204

Ep0162 50715
Durham, North Carolina 27705

Ep0162 50724
Portland, Oregon 97227

Ep0162 50096
Philadelphia, Pennsylvania 19104

Ep0162 50364
Philadelphia, Pennsylvania 19107

Ep0162 50089
Philadelphia, Pennsylvania 19140

Ep0162 50511
Pittsburgh, Pennsylvania 15212

Ep0162 50491
Pittsburgh, Pennsylvania 15213

Ep0162 50700
Chattanooga, Tennessee 37403

Ep0162 50513
Memphis, Tennessee 38103-2800

Ep0162 50103
Nashville, Tennessee 37232

Ep0162 50731
Austin, Texas 78749

Ep0162 50714
Houston, Texas 77030

Ep0162 50525
Houston, Texas 77459

Ep0162 50473
Salt Lake City, Utah 84132

Ep0162 50726
Winchester, Virginia 22601

More Details

Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
1-844-599-2273 (USA)
UCBCares@ucb.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.