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(904) 244-0411

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

  • Status
    Accepting Candidates
  • Age
    12 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

Study EP0162 is a double-blind, randomized, placebo-controlled, multi-center, parallel-group, Phase 3 study to investigate the efficacy and safety of Staccato alprazolam in an outpatient setting in study participants with epilepsy who are 18 years of age and older and have stereotypical prolonged seizures.

This study is sponsored by UCB Biopharma SRL. One qualifying prolonged seizure event per study participant will be treated with a single administration of an investigational medicinal product (IMP) in the outpatient setting. Study participants will be randomized at a 1:1 ratio to receive Staccato alprazolam (2mg) or placebo for the treatment of the qualifying prolonged seizure event.

The study will be divided into 3 periods:

  1. A Screening Period (including the Screening and Baseline/Randomization Visits),

  2. An Outpatient Treatment Period, and

  3. A Safety Follow-up (SFU) Period. There will be a minimum of 4 in-person visits, with potential options of remote visits, and 1 phone call over a maximum period of 133 days (19 weeks). There is a Safety Follow-up Period (SFP) (including an in-clinic SFU/Early Termination Visit (ET) Visit either within =5 to 12 days after IMP administration, after completion of the 12-week Outpatient Treatment Period without a qualifying prolonged seizure event, or as a consequence of early withdrawal/termination. The study staff is available via phone or email to answer your questions if you are interested in the trial or would like to get more information about the study.  

Details

Protocol number WIRB20216831

Eligibility

Main Inclusion Criteria are:

  • 12 years of age or older
  • Have focal or generalized epilepsy, or a combination of the two
  • Have experienced at least 2 prolonged seizures within the past 3 months
  • Have an adult who can act as a study partner to assist you throughout the study There are other criteria that you will need to meet to qualify, which the study staff will discuss with you and your study doctor.

Lead researchers

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.