RightFit
RecruitingPhase not listed

Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks

PHASES: Prodrome in tHe reAl World: aSsESsing Ubrogepant Acute Use

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 13 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for up to 13 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how severe migraine attacks are when adults take ubrogepant during early warning signs, before the headache starts. It is for adults with migraine who already use ubrogepant, a pill approved to treat migraine attacks. Participants will be followed for up to 13 weeks during their usual care.

Migraine is a neurological disease characterized by moderate or severe headaches, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess changes in migraine attack severity for adult participants treating with oral ubrogepant across migraine attacks. Ubrogepant is a drug that is approved for the acute treatment of migraine in adults. Approximately 189 participants will be enrolled in approximately 15 sites across the US. Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 13 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are an adult with a current doctor's diagnosis of migraine or chronic migraine.
  • Had 4 to 10 migraine days with moderate to severe headache pain each month for the 3 months before the first visit.
  • People with chronic migraine may join if medicine to prevent migraines has brought them into this range.
  • Currently have a prescription for ubrogepant and have used it for at least 3 months to treat migraine attacks as approved by the FDA.

Who can't join

  • Are currently taking part in another clinical or observational study.
  • Take a strong CYP3A4 inhibitor—a medicine that strongly blocks an enzyme that breaks down certain drugs.
  • Have a current diagnosis of new persistent daily headache (a new headache that becomes daily and does not stop), trigeminal autonomic cephalgia (certain headaches with signs such as watery eyes or a stuffy nose), status migrainosus (a long-lasting migraine attack), or painful cranial neuropathy (pain from damaged nerves in the head).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 --a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study * Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication * Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3 Exclusion Criteria: * Currently participating in a concurrent clinical or non-interventional study. * Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor. * Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3

Study sites (3)

CA

IL

NE