NCT05503082

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Ubrogepant Efficacy and Safety in the Treatment of Acute Migraine in Patients Currently Treated With CGRP Monoclonal Antibodies (CGRPmAbs)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Chicago Headache Center & Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to examine the safety and efficacy of ubrogepant (UBRELVY) in patients currently treated with one of the injectable monoclonal antibodies targeting CGRP or the CGRP receptor (Aimovig, Ajovy, or Emgality). There are currently very limited data available about the use of CGRP receptor antagonists in this population, resulting in difficulty obtaining prior authorization to use ubrogepant in patients currently treated with CGRPmAbs. Questions remain as to whether these patients, whose CGRP or CGRP receptors are suppressed, will experience the same safety and efficacy results as patients without such suppression by CGRPmAbs. 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. Primary Objective: To evaluate the safety and efficacy of ubrogepant (UBRELVY) in patients currently treated with one of the injectable monoclonal antibodies targeting CGRP or the CGRP receptor (Aimovig, Ajovy, or Emgality). Primary Endpoint: * Pain freedom at 2 hours. * Freedom from most bothersome symptom at 2 hours Secondary Objectives: To assess improvements with the addition of ubrogepant (UBRELVY) in patients currently treated with one of the injectable monoclonal antibodies targeting CGRP or the CGRP receptor (Aimovig, Ajovy, or Emgality). Secondary Endpoint: * Pain relief at 2 hours (this is different from pain freedom: moderate to severe pain reduced to mild or no pain) * Percentage of patients with sustained pain relief from 2-24 hours after initial dose * Percentage of patients with sustained pain freedom from 2-24 hours after initial dose * Pain relief at 2 hours after 2nd dose * Percentage of patients with sustained pain relief from 2-24 hours after 2nd dose * Percentage of patients with sustained pain freedom from 2-24 hours after 2nd dose

Conditions

• Headache, Migraine

Interventions

Type	Name	Description
DRUG	Ubrogepant 50 MG [Ubrelvy]	Ubrogepant 50 MG \[Ubrelvy\]
DRUG	Ubrogepant 100 MG [Ubrelvy]	Ubrogepant 100 MG \[Ubrelvy\]

Timeline

• Start date: 2022-09-06
• Primary completion: 2024-09-01
• Completion: 2024-11-01
• First posted: 2022-08-16
• Last updated: 2024-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study