Headache, MigrainePhase 4UNIONNCT05503082
Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
A Phase 4 study testing Ubrogepant 50 MG [Ubrelvy] and Ubrogepant 100 MG [Ubrelvy] in people with Headache, Migraine, run by Chicago Headache Center & Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Ubrogepant 50 MG [Ubrelvy] and Ubrogepant 100 MG [Ubrelvy]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2022to Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ages 18 to 75 years, at screening (Visit 1).
- At least a 1-year history of migraine with or without aura.
- History of ≥3 monthly headache days of at least moderate severity.
- Study patient currently on CGRPmAbs must be on treatment > 1 month at screening.
- By history, the patient's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
Who cannot join
- History of <3 monthly headache days of at least moderate severity
- Concomitant use of strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin, St. John's Wort)
- Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
- Currently on Botox treatment for CM.
- Concomitant use of gepants as a preventative treatment.
- Current user of illicit drugs, or a history within 1 year prior to screening (visit 1) of drug or alcohol abuse or dependence
- Clinically significant hematologic, endocrine, cardiovascular, pulmonary, gastrointestinal, or neurologic disease. If there is a history of such a disease, but the condition has been stable for more than 1 year prior to screening (visit 1) and is judged by the PI as not likely to interfere with participation in the study, the participant may be included.
- Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chicago Headache Center & Research Institute
Chicago, Illinois, 60657
Chicago Headache Center & Research Institute
Naperville, Illinois, 60563
About this study
Official title: Ubrogepant Efficacy and Safety in the Treatment of Acute Migraine in Patients Currently Treated With CGRP Monoclonal Antibodies (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.
Read the 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
- Being tested
- Ubrogepant 50 MG [Ubrelvy], Ubrogepant 100 MG [Ubrelvy]
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ubrogepant 50 MG [Ubrelvy]Drug
Ubrogepant 50 MG [Ubrelvy]
Ubrogepant 100 MG [Ubrelvy]Drug
Ubrogepant 100 MG [Ubrelvy]
| Study group | Role | What they receive |
|---|---|---|
| w/o CGRPmAb | Placebo comparator | w/o CGRPmAb Receives: Drug: Ubrogepant 50 MG [Ubrelvy]; Drug: Ubrogepant 100 MG [Ubrelvy] |
| Tx w/ CGRPmAb | Active comparator | Tx w/ CGRPmAb Receives: Drug: Ubrogepant 50 MG [Ubrelvy]; Drug: Ubrogepant 100 MG [Ubrelvy] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain freedom
Pain freedom at 2 hours.
Measured: 2 hours post treatment
Freedom from most bothersome symptom
Freedom from most bothersome symptom at 2 hours.
Measured: 2 hours post treatment
Secondary outcomes (6)
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).
Measured: 2 hours post treatment
Percentage of patients with sustained pain relief from 2-24 hours after initial dose.
Percentage of patients with sustained pain relief from 2-24 hours after initial dose.
Measured: 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.
Measured: 2-24 hours after initial dose
Pain relief at 2 hours after 2nd dose
Pain relief at 2 hours after 2nd dose.
Measured: 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.
Measured: 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.
Measured: 2-24 hours after 2nd dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start6 Sep 2022
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chicago Headache Center & Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Bradley Torphy, MD, Chicago Headache Center & Research Institute
- Investigators
- Bradley Torphy, MD, Principal investigator, Chicago Headache Center & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503082
- Sponsor's protocol ID
- 2020-02
- Acronym
- UNION
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32073660
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ubrogepant Efficacy and Safety in the Treatment of Acute Migraine in Patients Currently Treated With CGRP Monoclonal Antibodies (CGRPmAbs)
- ClinicalTrials.gov ID
- NCT05503082
- Acronym / sponsor ID
- UNION / 2020-02
- Conditions
- Headache, Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Chicago Headache Center & Research InstituteUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| w/o CGRPmAb | Placebo comparator | Drug: Ubrogepant 50 MG [Ubrelvy], Drug: Ubrogepant 100 MG [Ubrelvy]w/o CGRPmAb |
| Tx w/ CGRPmAb | Active comparator | Drug: Ubrogepant 50 MG [Ubrelvy], Drug: Ubrogepant 100 MG [Ubrelvy]Tx w/ CGRPmAb |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients ages 18 to 75 years, at screening (Visit 1).
- At least a 1-year history of migraine with or without aura.
- History of ≥3 monthly headache days of at least moderate severity.
- Study patient currently on CGRPmAbs must be on treatment > 1 month at screening.
- By history, the patient's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
Key exclusion criteria (8 listed)
- History of <3 monthly headache days of at least moderate severity
- Concomitant use of strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin, St. John's Wort)
- Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
- Currently on Botox treatment for CM.
- Concomitant use of gepants as a preventative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ubrogepant 50 MG [Ubrelvy]Ubrogepant 50 MG [Ubrelvy] | Drug | Tx w/ CGRPmAb, w/o CGRPmAb |
| Ubrogepant 100 MG [Ubrelvy]Ubrogepant 100 MG [Ubrelvy] | Drug | Tx w/ CGRPmAb, w/o CGRPmAb |
Primary outcome
Pain freedom
Time frame: 2 hours post treatment
Pain freedom at 2 hours.
Freedom from most bothersome symptom
Time frame: 2 hours post treatment
Freedom from most bothersome symptom at 2 hours.
6 secondary outcomes
Pain relief at 2 hours
Time frame: 2 hours post treatment
Percentage of patients with sustained pain relief from 2-24 hours after initial dose.
Time frame: 2-24 hours after initial dose
Percentage of patients with sustained pain freedom from 2-24 hours after initial dose.
Time frame: 2-24 hours after initial dose
Pain relief at 2 hours after 2nd dose
Time frame: 2 hours after 2nd dose
Percentage of patients with sustained pain relief from 2-24 hours after 2nd dose.
Time frame: 2-24 hours after 2nd dose
Percentage of patients with sustained pain freedom from 2-24 hours after 2nd dose.
Time frame: 2-24 hours after 2nd dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 32073660Dodick 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.
- Chicago Headache Center \& Research InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Torphy, MD principal investigator
Chicago Headache Center & Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ubrogepant 50 MG [Ubrelvy] and Ubrogepant 100 MG [Ubrelvy] in people with Headache, Migraine, run by Chicago Headache Center & Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain freedom (time frame: 2 hours post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.