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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| w/o CGRPmAb | Placebo Comparator | w/o CGRPmAb |
|
| Tx w/ CGRPmAb | Active Comparator | Tx w/ CGRPmAb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubrogepant 50 MG [Ubrelvy] | Drug | Ubrogepant 50 MG [Ubrelvy] |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain freedom | Pain freedom at 2 hours. | 2 hours post treatment |
| Freedom from most bothersome symptom | Freedom from most bothersome symptom at 2 hours. | 2 hours post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief at 2 hours | Pain relief at 2 hours (this is different from pain freedom: moderate to severe pain reduced to mild or no pain). | 2 hours post treatment |
| Percentage of patients with sustained pain relief from 2-24 hours after initial dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Torphy, MD | Chicago Headache Center & Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Headache Center & Research Institute | Chicago | Illinois | 60657 | United States | ||
| Chicago Headache Center & Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32073660 | Background | Dodick DW, Lipton RB, Ailani J, Halker Singh RB, Shewale AR, Zhao S, Trugman JM, Yu SY, Viswanathan HN. Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II. Headache. 2020 Apr;60(4):686-700. doi: 10.1111/head.13766. Epub 2020 Feb 19. |
| Label | URL |
|---|---|
| Chicago Headache Center \& Research Institute | View source |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000615620 | ubrogepant |
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Phase IV prospective open label randomized clinical study evaluating 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).
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| Ubrogepant 100 MG [Ubrelvy] |
| Drug |
Ubrogepant 100 MG [Ubrelvy] |
|
Percentage of patients with sustained pain relief from 2-24 hours after initial dose.
| 2-24 hours after initial dose |
| Percentage of patients with sustained pain freedom from 2-24 hours after initial dose. | Percentage of patients with sustained pain freedom from 2-24 hours after initial dose. | 2-24 hours after initial dose |
| Pain relief at 2 hours after 2nd dose | Pain relief at 2 hours after 2nd dose. | 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 relief from 2-24 hours after 2nd dose. | 2-24 hours after 2nd dose |
| Percentage of patients with sustained pain freedom from 2-24 hours after 2nd dose. | Percentage of patients with sustained pain freedom from 2-24 hours after 2nd dose. | 2-24 hours after 2nd dose |
| Naperville |
| Illinois |
| 60563 |
| United States |
| D009422 | Nervous System Diseases |