MigrainePhase 1NCT04818515
Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine
A Phase 1 study testing Atogepant and Ubrogepant in people with Migraine, run by AbbVie at 3 sites in United States.
Trial summary
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Atogepant and Ubrogepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Mar 2021to 18 Jun 2021
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) (2018) and is eligible for preventive migraine treatment.
- By history, the participant'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.
- History of at least 2 migraine attacks per month in the 2 months prior to screening.
- Sitting heart rate ≥ 45 bpm and ≤ 100 bpm during the vital signs assessment at the Screening Visit. The clinical site may perform a maximum of 2 repeats of vital sign measurements if the initial measurement is out of range.
- Negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the Screening Visit and Day -1; unless explained by concomitant medication use (eg, opioids prescribed for migraine pain).
- Must be a nonsmoker and a nonuser of nicotine-containing products (never smoked or used nicotine-containing products or has not smoked or used nicotine-containing products within the previous 2 years, including eCigarettes).
Who cannot join
- Difficulty distinguishing migraine headache from tension-type or other headaches.
- Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3.
- Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to screening.
- Has a chronic non-headache pain condition requiring daily pain medication (with the exception of pregabalin).
- Clinically significant cardiovascular or cerebrovascular disease per the investigator's opinion including, but not limited to:
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- Clinically significant ischemic heart disease (eg, unstable angina pectoris).
- Clinically significant cardiac rhythm or conduction abnormalities (eg, atrial fibrillation, second- or third-degree heart block) or risk factors for torsade de pointes (eg, heart failure, hypokalemia, bradycardia).
- Myocardial infarction, transient ischemic attack, or stroke within 6 months prior to screening.
- Heart failure defined as New York Heart Association functional classification system Class III or IV.
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
- In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or other significant neurological disorders other than migraine.
- History of malignancy in the 5 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) or previous surgery that may affect the absorption or metabolism of study interventions; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded.
- History of acute hepatitis within 6 months of screening or chronic hepatitis (including nonalcoholic steatohepatitis) or a positive result on anti-human immunodeficiency virus (HIV) type 1 and type 2 antibody, hepatitis B surface antigen (HBsAg), or anti-hepatitis C antibody testing at screening.
- Coronavirus disease 2019 (COVID-19) infection and/or COVID-19 or flu-like symptoms within 14 days of Day 1, including fever, cough, difficulty breathing.
- Close contact with anyone who has a COVID-19 infection within 14 days before Day 1.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PPD Clinical Research Unit /ID# 227676
Orlando, Florida, 32806-1044
Bio-Kinetic Clinical Applications, LLC /ID# 227675
Springfield, Missouri, 65802-4842
Spaulding Clinical Research LLC /ID# 229505
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1b, Open-label, Fixed-sequence, Safety, Tolerability and Drug-drug Interaction Study Between Atogepant and Ubrogepant in Participants With a History of Migraine
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine.
Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States.
Read more
Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
- Conditions
- Migraine
- Being tested
- Atogepant, Ubrogepant
- Keywords
- Migraine, Atogepant, Ubrogepant, 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.
AtogepantDrug
Oral; Tablet
UbrogepantDrug
Also called UBRELVY
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Atogepant, Ubrogepant, and Coadministration | Experimental | Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination, for a 30 day interventional period and a 7 day follow up period. Receives: Drug: Atogepant; Drug: Ubrogepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant is Administered
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when Ubrogepant is administered.
Measured: Day 1
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant and Atogepant are Coadministered
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when ubrogepant and atogepant are coadministered.
Measured: Day 1
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf), when Ubrogepant is Administered
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when Ubrogepant is administered.
Measured: Day 1
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf), when when Ubrogepant and Atogepant are Coadministered
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when ubrogepant and atogepant are coadministered.
Measured: Day 1
Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State (AUCtau), when Atogepant is Administered
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when Atogepant is administered.
Measured: Day 6
Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State (AUCtau), when Ubrogepant and Atogepant are Coadministered
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when ubrogepant and atogepant are coadministered.
Measured: Day 6
Maximum Plasma Drug Concentration (Cmax) when Ubrogepant is Administered
Maximum plasma drug concentration (Cmax) when ubrogepant is administered.
Measured: Day 1
Maximum Plasma Drug Concentration (Cmax) when Atogepant is Administered
Maximum plasma drug concentration (Cmax) when atogepant is administered.
Measured: Day 6
Maximum Plasma Drug Concentration (Cmax) of Ubrogepant when Ubrogepant and Atogepant are Coadministered
Maximum plasma drug concentration (Cmax) of ubrogepant when ubrogepant and atogepant are coadministered.
Measured: Day 7
Maximum Plasma Drug Concentration (Cmax) of Atogepant when Ubrogepant and Atogepant are Coadministered
Maximum plasma drug concentration (Cmax) of atogepant when ubrogepant and atogepant are coadministered.
Measured: Day 7
Secondary outcomes (6)
Number of Participants with Abnormal Change in Physical Examinations
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Measured: Up to Day 28
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to Day 28
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Measured: Up to Day 28
Change From Baseline in Electrocardiograms (ECGs)
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Measured: Up to Day 28
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Measured: Up to Day 29
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to Day 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start17 Mar 2021
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818515
- Sponsor's protocol ID
- 3101-106-002
- Status last verified
- Jun 2022
- First submitted
- 24 Mar 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Fixed-sequence, Safety, Tolerability and Drug-drug Interaction Study Between Atogepant and Ubrogepant in Participants With a History of Migraine
- ClinicalTrials.gov ID
- NCT04818515
- Acronym / sponsor ID
- 3101-106-002
- Conditions
- Migraine
- Keywords
- Migraine, Atogepant, Ubrogepant, UBRELVY
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 26 Mar 2021 (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.
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine.
Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States.
Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atogepant, Ubrogepant, and Coadministration | Experimental | Drug: Atogepant, Drug: UbrogepantParticipants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination, for a 30 day interventional period and a 7 day follow up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) (2018) and is eligible for preventive migraine treatment.
- By history, the participant'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.
- History of at least 2 migraine attacks per month in the 2 months prior to screening.
- Sitting heart rate ≥ 45 bpm and ≤ 100 bpm during the vital signs assessment at the Screening Visit. The clinical site may perform a maximum of 2 repeats of vital sign measurements if the initial measurement is out of range.
- Negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the Screening Visit and Day -1; unless explained by concomitant medication use (eg, opioids prescribed for migraine pain).
Key exclusion criteria (17 listed)
- Difficulty distinguishing migraine headache from tension-type or other headaches.
- Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3.
- Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to screening.
- Has a chronic non-headache pain condition requiring daily pain medication (with the exception of pregabalin).
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 |
|---|---|---|
| AtogepantOral; Tablet | Drug | Atogepant, Ubrogepant, and Coadministration |
| UbrogepantAlso: UBRELVYOral; Tablet | Drug | Atogepant, Ubrogepant, and Coadministration |
Primary outcome
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant is Administered
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when Ubrogepant is administered.
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant and Atogepant are Coadministered
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when ubrogepant and atogepant are coadministered.
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf), when Ubrogepant is Administered
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when Ubrogepant is administered.
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf), when when Ubrogepant and Atogepant are Coadministered
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when ubrogepant and atogepant are coadministered.
Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State (AUCtau), when Atogepant is Administered
Time frame: Day 6
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when Atogepant is administered.
Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State (AUCtau), when Ubrogepant and Atogepant are Coadministered
Time frame: Day 6
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when ubrogepant and atogepant are coadministered.
Maximum Plasma Drug Concentration (Cmax) when Ubrogepant is Administered
Time frame: Day 1
Maximum plasma drug concentration (Cmax) when ubrogepant is administered.
Maximum Plasma Drug Concentration (Cmax) when Atogepant is Administered
Time frame: Day 6
Maximum plasma drug concentration (Cmax) when atogepant is administered.
Maximum Plasma Drug Concentration (Cmax) of Ubrogepant when Ubrogepant and Atogepant are Coadministered
Time frame: Day 7
Maximum plasma drug concentration (Cmax) of ubrogepant when ubrogepant and atogepant are coadministered.
Maximum Plasma Drug Concentration (Cmax) of Atogepant when Ubrogepant and Atogepant are Coadministered
Time frame: Day 7
Maximum plasma drug concentration (Cmax) of atogepant when ubrogepant and atogepant are coadministered.
6 secondary outcomes
Number of Participants with Abnormal Change in Physical Examinations
Time frame: Up to Day 28
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Time frame: Up to Day 28
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to Day 28
Change From Baseline in Electrocardiograms (ECGs)
Time frame: Up to Day 28
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 29
Number of Participants with Adverse Events (AE)
Time frame: Up to Day 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- 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.
ABBVIE INC. study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atogepant and Ubrogepant in people with Migraine, run by AbbVie at 3 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant is Administered (time frame: Day 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2022.