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Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

NCT05503082 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-08-20

No results posted yet for this study

Summary

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.

Conditions

  • Headache, Migraine

Interventions

DRUG

Ubrogepant 50 MG [Ubrelvy]

Ubrogepant 50 MG \[Ubrelvy\]

DRUG

Ubrogepant 100 MG [Ubrelvy]

Ubrogepant 100 MG \[Ubrelvy\]

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Chicago Headache Center & Research Institute

    lead OTHER

Principal Investigators

  • Bradley Torphy, MD · Chicago Headache Center & Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2024-09-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05503082 on ClinicalTrials.gov