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EpilepsyPhase 1NCT04857307

A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

A Phase 1 study testing Alprazolam in people with Epilepsy, run by UCB Biopharma SRL at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Epilepsy
What is being tested?
Alprazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
8 sitesUnited States
Study dates
28 Apr 2021to 5 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participant must be 12 to 17 years of age inclusive, at the time of signing the Informed Consent form (ICF) and the Assent form
  • Participant has an established diagnosis of focal, generalized, or focal and generalized epilepsy
  • Participant is in good general health as determined by medical evaluation including medical history and physical examination
  • Participants with a body weight ≥29 kg and body mass index (BMI) within the range 14 to 32 kg/m^2 (inclusive)
  • A male participant must agree to use contraception
  • A female participant is eligible to participate if she is not pregnant
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  • Participant is capable of and provides assent, and the study participant's parent/legal representative provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the ICF, Assent form, and in this protocol
  • Participant has a lifetime history of never smoking >5 cigarettes/day, and a current history (for at least 6 months prior to Screening Visit) of not smoking at all (including e-cigarette and vaping products)
  • Participant has forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >80% predicted at Screening. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out-of-range again, the study participant will be excluded
  • Participant is willing and able to be confined to a clinical research facility for up to 36 hours (including 1 overnight stay) and comply with the study schedule and study requirements.
  • Note: If there are no clinical contraindications, as per Investigator's judgment, study participants may leave the clinical research facility after the 6-hour postdose assessments and return to the clinic on Day 2 for the 24-hour and 36-hour postdose assessments
  • Participant is currently taking at least 1 background antiepileptic drug (AED)
  • Participant is able to actuate the training device during Screening, according to Instructions for Use

Who cannot join

  • Participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, hematological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of Investigational Medicinal Product (IMP); constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the Investigator
  • Participant has a known hypersensitivity to any components of the IMP or comparative drugs (and/or an investigational device) as stated in the protocol
  • Participant has severe chronic cardio-respiratory disease
  • Participant has history of acute narrow angle glaucoma, hydrocephalus, or Myasthenia Gravis
  • Participant has history or has current airway disease such asthma, cystic fibrosis, or chronic obstructive pulmonary disease
  • Participant has any acute respiratory signs/symptoms (ie, wheezing) and active acute respiratory infection (or within 1 week of dosing) with exception of symptoms of mild rhinitis
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  • Participant has a known hypersensitivity to albuterol or similar short-acting beta2-agonist (SABA) that may be used as rescue medication administered in response to potential bronchospasm
  • Participant is taking strong liver inducing agents (eg, phenytoin, phenobarbital, carbamazepine, and primidone) or strong Cytochrome P450 3A4 (CYP3A4) inhibitors
  • Participant has a SpO2 measured by pulse oximetry <95% for >30 seconds during the Screening Visit

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Up0100 101

    Bethesda, Maryland, 20817

  • Up0100 106

    Cincinnati, Ohio, 45229

  • Up0100 103

    Honolulu, Hawaii, 96817

  • Up0100 102

    Little Rock, Arkansas, 72205

  • Up0100 105

    Memphis, Tennessee, 38103

  • Up0100 110

    Orlando, Florida, 32806

  • Up0100 108

    Rochester, New York, 14642

  • Up0100 107

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.

Conditions
Epilepsy
Being tested
Alprazolam
Keywords
Epilepsy, Staccato alprazolam, Phase 1, Adolescents, STAP-001, Alprazolam
Medical subject headings
Epilepsy

What participants receive

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

  • AlprazolamDrug

    Also called UCB7538

    • Pharmaceutical form: Inhalation powder.
    • Study participants will receive Staccato alprazolam at prespecified time-points.
Study groups in NCT04857307
Study groupRoleWhat they receive
Staccato alprazolamExperimentalThe study participants will receive a single dose of Staccato alprazolam.
Receives: Drug: Alprazolam

What is being measured

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

  1. Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam

    Cmax = Maximum plasma concentration.

    Measured: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.

  2. Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)) following single inhaled dose of Staccato alprazolam

    AUC(0-t) = Area under the plasma concentration-time curve from zero to the last quantifiable concentration.

    Measured: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.

  3. Area under the plasma concentration-time curve from time 0 to infinity (AUC) following single inhaled dose of Staccato alprazolam

    AUC = Area under the plasma concentration-time curve from time 0 to infinity.

    Measured: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.

  4. Apparent total body clearance (CL/F) following single inhaled dose of Staccato alprazolam

    CL/F = Apparent total body clearance.

    Measured: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.

  5. Percentage of participants with treatment-emergent adverse event (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 baseline (Day 1) till end of Safety Follow-up (up to Day 9)

  6. Percentage of participants with serious treatment-emergent adverse event (serious TEAEs)

    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

    1. Results in death c. Requires inpatient hospitalization or prolongation of existing hospitalization d. Results in persistent disability/incapacity e. Is a congenital anomaly/birth defect f. Important medical events.

    Measured: From baseline (Day 1) till end of Safety Follow-up (up to Day 9)

Timeline

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

  1. First posted23 Apr 2021
  2. Study start28 Apr 2021
  3. Primary completion5 Apr 2022
  4. Study completion5 Apr 2022

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 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857307
Sponsor's protocol ID
UP0100
Status last verified
Jun 2022
First submitted
22 Apr 2021
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alprazolam in people with Epilepsy, run by UCB Biopharma SRL at 8 sites in United States.

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 13 inclusion and 9 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: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam (time frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.). The study lists 6 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 NCT04857307.

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 30 Jun 2022.

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