Featured Trial

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6‑17)

Study Identifier
3110-305-002
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Migraine is a severe, chronic neurological disease characterized by episodic attacks of moderate-to-severe headache, sensory disturbances, and other symptoms. Migraine represents a major cause of disability in adults and in children. Although the peak prevalence of the condition typically occurs during adulthood, migraine represents one of the most common childhood ailments.

The PERISCOPE Study is evaluating an investigational product (ubrogepant) for the treatment of migraine in children and adolescents between the ages of 6 to 17. The investigational product is currently approved to treat migraine in adults. It is unknown if the investigational product is safe or effective in children.

Medical Condition
  • Migraine - General
  • Study Drug
  • Ubrogepant
  • Placebo-Matching Ubrogepant
  • Phase
    Phase 3
    Estimated Enrollment
    1059 patients

    Participating in our Pediatric Migraine Clinical Trials

    If you qualify, the PERISCOPE study will include 2-3 visits to a study site in your location. Your child’s participation may be as short as several weeks or up to 6 months. Eligible participants will be randomly assigned to receive the investigational product (ubrogepant) or placebo (a substance that looks like the active drug but contains no active medicine). Both will be administered as oral tablets. The study doctor, you, and your child will not know if you are receiving active drug or placebo (double-blind).

    Participants will attend regular visits during the study at a hospital or clinic. The outcome of the treatment will be reviewed by medical assessments, blood tests, evaluation of side effects and completion of questionnaires. After completing this study, your child may have the opportunity to participate in the extension study to receive ubrogepant (open-label) for approximately 1 year [NCT05127954].

    All study-related visits, tests, and the investigational drugs will be provided at no cost. In addition, you may receive compensation for your time and travel. Health insurance is not required for participation.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    6 - 17 Years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be 6 to 17 years old
    • Weigh ≥ 20 kg (44 pounds) and < 135 kg (298 pounds)
    • Have a history of migraine for at least 6 months
    • Have a history of 1-14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening

    Participants must not:

    • Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease
    • Have a history of cancer in the past 5 years
    • Have a current diagnosis of chronic migraine

    Study Locations

    Location
    Status
    Location
    Rehabilitation & Neurological Services /ID# 229969
    Huntsville, Alabama, United States, 35805-4046
    Status
    Recruiting
    Location
    The Center for Clinical Trials - Saraland /ID# 231546
    Saraland, Alabama, United States, 36571
    Status
    Recruiting
    Location
    Rezen Clinical Trials /ID# 282831
    Glendale, Arizona, United States, 85306
    Status
    Not yet recruiting
    Location
    Velocity Clinical Research - Phoenix /ID# 274478
    Phoenix, Arizona, United States, 85006
    Status
    Recruiting
    Location
    HealthStar Research Glenwood /ID# 275303
    Glenwood, Arkansas, United States, 71943
    Status
    Recruiting
    Location
    HealthStar Research of Hot Springs /ID# 273256
    Hot Springs, Arkansas, United States, 71913
    Status
    Recruiting
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    UBRV-US-0073-RM Version 1.0 Oct2025