Stereotypical Prolonged SeizuresPhase 3NCT05076617
A Study to Test the Safety and Tolerability 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 136 sites in 12 countries.
Trial summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam. 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?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 136 sitesin 12 countries
- Study dates
- 3 Feb 2022to 30 Nov 2028
- 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 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:
- 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
- Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))
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 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
Show all 13Show fewer
- 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
Trial locations and contacts
136 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
136 sites in 12 countries
United States48 sites
Ep0165 50497
Amherst, New York, 14226
Ep0165 50731
Austin, Texas, 78749
Ep0165 50512
Boise, Idaho, 83702
Ep0165 50615
Boston, Massachusetts, 02118
Ep0165 50047
Boston, Massachusetts, 02215
Ep0165 50514
Charlotte, North Carolina, 28204
Ep0165 50700
Chattanooga, Tennessee, 37403
Ep0165 50493
Chicago, Illinois, 60611
Ep0165 50118
Downey, California, 90242
Ep0165 50715
Durham, North Carolina, 27705
Ep0165 50504
Fort Wayne, Indiana, 46845
Ep0165 50515
Gulf Breeze, Florida, 32561
Ep0165 50323
Honolulu, Hawaii, 96817
Ep0165 50714
Houston, Texas, 77030
Ep0165 50525
Houston, Texas, 77459
Ep0165 50508
Jacksonville, Florida, 32209-6533
Ep0165 50342
Jacksonville, Florida, 32224
Ep0165 50416
La Jolla, California, 92037
Ep0165 50494
Little Rock, Arkansas, 72205
Ep0165 50702
Long Beach, California, 90806
Ep0165 50513
Memphis, Tennessee, 38103-2800
Ep0165 50199
Miami, Florida, 33136
Ep0165 50676
Miami, Florida, 33176
Ep0165 50103
Nashville, Tennessee, 37232
Ep0165 50299
New Brunswick, New Jersey, 08901
Ep0165 50625
New Hyde Park, New York, 11042
Ep0165 50517
New Orleans, Louisiana, 70122
Ep0165 50298
New York, New York, 10016
Ep0165 50490
New York, New York, 10029
Ep0165 50518
New York, New York, 10075
Ep0165 50509
Orlando, Florida, 32806
Ep0165 50096
Philadelphia, Pennsylvania, 19104
Ep0165 50364
Philadelphia, Pennsylvania, 19107
Ep0165 50089
Philadelphia, Pennsylvania, 19140
Ep0165 50506
Phoenix, Arizona, 85004
Ep0165 50511
Pittsburgh, Pennsylvania, 15212
Ep0165 50491
Pittsburgh, Pennsylvania, 15213
Ep0165 50701
Portland, Oregon, 97239
Ep0165 50722
Poway, California, 92064
Ep0165 50034
Rochester, New York, 14642
Ep0165 50703
Rockledge, Florida, 32955
Ep0165 50716
Sacramento, California, 95817
Ep0165 50473
Salt Lake City, Utah, 84132
Ep0165 50720
Scottsdale, Arizona, 85253
Ep0165 50507
St Louis, Missouri, 63110
Ep0165 50308
Tampa, Florida, 33606
Ep0165 50088
Washington D.C., District of Columbia, 20037
Ep0165 50726
Winchester, Virginia, 22601
China25 sites
Ep0165 20246
Beijing
Ep0165 20268
Beijing
Ep0165 20299
Beijing
Ep0165 20261
Changchun
Ep0165 20133
Chengdu
Ep0165 20137
Chengdu
Ep0165 20334
Chongqing
Ep0165 20179
Fuzhou
Ep0165 20124
Guangzhou
Ep0165 20264
Guangzhou
Ep0165 20269
Guangzhou
Ep0165 20300
Guangzhou
Ep0165 20022
Hangzhou
Ep0165 20320
Kunming
Ep0165 20258
Lanzhou
Ep0165 20267
Nanjing
Ep0165 20331
Nanning
Ep0165 20333
Qingdao
Ep0165 20292
Shanghai
Ep0165 20289
Shijiazhuang
Ep0165 20119
Suzhou
Ep0165 20257
Tianjin
Ep0165 20025
Wenzhou
Ep0165 20262
Zhanjiang
Ep0165 20251
Zhengzhou
Japan18 sites
Ep0165 20248
Fukuoka
Ep0165 20070
Hachioji-shi
Ep0165 20249
Hiroshima
Ep0165 20236
Hōfu
Ep0165 20239
Itami
Ep0165 20143
Kodaira
Ep0165 20315
Koshi-shi
Ep0165 20147
Kyoto
Ep0165 20238
Niigata
Ep0165 20241
Ōmura
Ep0165 20302
Osaka
Ep0165 20316
Sapporo
Ep0165 20337
Shimotsuga-gun
Ep0165 20297
Shinjuku-ku
Ep0165 20240
Shizuoka
Ep0165 20242
Suita
Ep0165 20266
Tōon
Ep0165 20244
Yamagata
Spain8 sites
Ep0165 40160
Barcelona
Ep0165 40157
L'Hospitalet de Llobregat
Ep0165 40540
Madrid
Ep0165 40352
Pamplona
Ep0165 40668
Seville
Ep0165 40453
Terrassa
Ep0165 40230
Valencia
Ep0165 40667
Valladolid
Poland6 sites
Ep0165 40707
Bydgoszcz
Ep0165 40677
Gdansk
Ep0165 40842
Krakow
Ep0165 40676
Lublin
Ep0165 40091
Nowa Sól
Ep0165 40678
Świdnik
Czechia5 sites
Ep0165 40670
Brno
Ep0165 40672
Ostrava - Poruba
Ep0165 40063
Prague
Ep0165 40671
Prague
Ep0165 40714
Prague
Germany5 sites
Ep0165 40683
Berlin
Ep0165 40685
Bielefeld
Ep0165 40023
Erlangen
Ep0165 40645
Frankfurt am Main
Ep0165 40529
Marburg
Italy5 sites
Ep0165 40674
Genova
Ep0165 40144
Milan
Ep0165 40477
Pavia
Ep0165 40257
Roma
Ep0165 40675
Roma
United Kingdom5 sites
Ep0165 40686
Birmingham
Ep0165 40735
Glasgow
Ep0165 40833
London
Ep0165 40163
Oxford
Ep0165 40108
Salford
Bulgaria4 sites
Ep0165 40650
Blagoevgrad
Ep0165 40708
Pazardzhik
Ep0165 40665
Pleven
Ep0165 40651
Sofia
Hungary4 sites
Ep0165 40666
Balassagyarmat
Ep0165 40673
Budapest
Ep0165 40704
Budapest
Ep0165 40653
Debrecen
Australia3 sites
Ep0165 30016
Fitzroy
Ep0165 30030
Herston
Ep0165 30031
South Brisbane
About this study
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
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
- Conditions
- Stereotypical Prolonged Seizures
- Being tested
- Staccato alprazolam
- 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
- Pharmaceutical form: Inhalation powder
- Route of administration: Inhalation
Participants will receive Staccato alprazolam during the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Staccato alprazolam | Experimental | Participants will receive Staccato alprazolam by inhalation. Receives: Drug: Staccato alprazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment-emergent adverse events (TEAEs)
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Measured: From Baseline up to the End of Study Visit (up to 78 months)
Frequency of TEAEs leading to withdrawal from study
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Measured: From Baseline up to the End of Study Visit (up to 78 months)
Frequency of serious TEAEs
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires inpatient hospitalisation or prolongation of existing hospitalisation
- Results in persistent or significant disability/incapacity, or
- Is a congenital anomaly/birth defect
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Measured: From Baseline up to the End of Study Visit (up to 78 months)
Secondary outcomes (3)
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
A responder after up to a maximum of 10 treated seizures will be defined as having a termination of seizure within 90 seconds after IMP dministration.
Measured: From start of IMP treatment up to 12 months
Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
A responder after up to a maximum of 10 treated seizures will be defined as termination of 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 up to 12 months
Frequency of respiratory TEAEs
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Measured: From Baseline up to the End of Study Visit (up to 78 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start3 Feb 2022
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotypical Prolonged SeizuresStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076617
- Sponsor's protocol ID
- EP0165
- Other IDs
- 2021-002637-42, 2023-508868-30, U1111-1299-3027, 2023
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2021
- Last updated
- 25 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05076617
- Acronym / sponsor ID
- EP0165
- Conditions
- Stereotypical Prolonged Seizures
- Keywords
- Stereotypical prolonged seizures, Phase 3, Staccato alprazolam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staccato alprazolam | Experimental | Drug: Staccato alprazolamParticipants will receive Staccato alprazolam by inhalation. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staccato alprazolamAlso: UCB7538* Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period. | Drug | Staccato alprazolam |
Primary outcome
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Frequency of TEAEs leading to withdrawal from study
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
Frequency of serious TEAEs
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
3 secondary outcomes
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
Time frame: From start of IMP treatment up to 12 months
Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
Time frame: From start of IMP treatment up to 12 months
Frequency of respiratory TEAEs
Time frame: From Baseline up to the End of Study Visit (up to 78 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Stereotypical Prolonged Seizures
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
UCB Cares study director
001 844 599 2273 (UCB)
136 sites in 12 countries: see every site and its status.
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 136 sites in 12 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 7 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 136 sites in United States, China, Japan, Spain, Poland and 7 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent adverse events (TEAEs) (time frame: From Baseline up to the End of Study Visit (up to 78 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.