Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Chicago Headache Center & Research Institute
Study ID
NCT05503082
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Headache, Migraine

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Key Dates

Start date
Sep 6, 2022
Status verified
Aug 2024
Primary completion
Sep 30, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
164 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: w/o CGRPmAb
    w/o CGRPmAb
  • Active Comparator: Tx w/ CGRPmAb
    Tx w/ CGRPmAb

Primary Outcome Measure

Pain freedom [ Time Frame: 2 hours post treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Chicago Headache Center & Research InstituteChicagoIllinois60657-
Chicago Headache Center & Research InstituteNapervilleIllinois60563-

Find similar trials in Chicago, IL

By research site
Chicago Headache Center & Research Institute· Chicago, ILChicago Headache Center & Research Institute· Naperville, IL

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