Migraine With AuraPhase 4ATOMNCT05214001
Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine
A Phase 4 study testing Almotriptan 12.5 Mg Oral Tablet and Ubrogepant 50Mg Tab in people with Migraine With Aura and Migraine Without Aura, run by Messoud Ashina, MD at 1 site in Denmark.
Trial summary
In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Almotriptan 12.5 Mg Oral Tablet and Ubrogepant 50Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jun 2022to 15 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Aged 18 to 65 years upon entry into screening
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-3 criteria based on medical records and/or patient self-report.
- Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.
Who cannot join
- Disease Related
- Greater than 50 years of age at migraine onset
- History of cluster headache or hemiplegic migraine headache
- Inability to differentiate between migraine from other headaches
- Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per months in the previous 3 months
- Has a history of migraine aura with diplopia or impairment of levels of consciousness, hemiplegic migraine, or retinal migraine.
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- Required hospital treatment of a migraine attack 3 or more times in the previous 6 months.
- Other Medical Conditions
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Has a chronic non-headache pain condition requiring daily pain medication
- Has a history of any prior gastrointestinal conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded.
- Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Medication related
- Start of new preventive migraine treatment within the last two months
- Change in dosage of ongoing preventive migraine treatment within the last two months
- Current treatment with monoclonal antibodies targeting calcitonin gene related piptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcaneszumab or atogeptant)
- Changes in treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) within the last two months
- Use of the following medication within 30 days prior to screening:
- Strong and moderate cytochrome P450 3A4 (CYP3A4) inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant; cyclosporine; nefazodone; cimetidine; quinine; and HIV protease inhibitors
- Strong and moderate CYP3A4 inducers, including but not limited to barbiturates (eg, phenobarbital and primidone), systemic (oral/IV) glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, rifampin, rifabutin, and St. John's wort
- Inhibitors of the BCRP (breast cancer resistance protein) transporter (eg, rifampicin)
- Drugs with narrow therapeutic margins (eg, digoxin, warfarin)
- Other Exclusions
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
- Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
- Evidence of current pregnancy or breastfeeding per subject self-report or medical records
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM).
In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.
Read the detailed description
The study is a randomized, open-label, parallel-group, single-attack study with 12.5 mg almotriptan and 50 mg ubrogepant. 645 patients with migraine with or without aura according to the third edition of the International Classification of Headache Disorders (ICHD-3) will be included.
Each subject will randomly be allocated to one treatment, and given 42 days to treat a single qualifying migraine attack of moderate to severe intensity.
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Almotriptan 12.5 Mg Oral Tablet, Ubrogepant 50Mg Tab
- Medical subject headings
- Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almotriptan 12.5 Mg Oral TabletDrug
Also called Almogran
Treatment for an acute, moderate to severe migraine attack
Ubrogepant 50Mg TabDrug
Also called Ubrelvy
Treatment for an acute, moderate to severe migraine attack
| Study group | Role | What they receive |
|---|---|---|
| Almotriptan | Experimental | 12.5 mg almotriptan taken orally once Receives: Drug: Almotriptan 12.5 Mg Oral Tablet |
| Ubrogepant | Active comparator | 50 mg ubrogepant taken orally once Receives: Drug: Ubrogepant 50Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain freedom at 2 hours
Pain freedom will be subjectively rated by the patient in a headache diary (yes or no).
Measured: 2 hours after initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start30 Jun 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Why it stopped: Issues with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Messoud Ashina, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Messoud Ashina, MD, Danish Headache Center
- Investigators
- Messoud Ashina, Prof., Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214001
- Sponsor's protocol ID
- 270221
- Other IDs
- 2021-001087-24
- Acronym
- ATOM
- Status last verified
- May 2025
- First submitted
- 11 Jan 2022
- Last updated
- 31 May 2025
- 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM).
- ClinicalTrials.gov ID
- NCT05214001
- Acronym / sponsor ID
- ATOM / 270221
- Conditions
- Migraine With Aura, Migraine Without Aura
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Messoud Ashina, MDUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 28 Jan 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.
In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.
Detailed description
The study is a randomized, open-label, parallel-group, single-attack study with 12.5 mg almotriptan and 50 mg ubrogepant. 645 patients with migraine with or without aura according to the third edition of the International Classification of Headache Disorders (ICHD-3) will be included.
Each subject will randomly be allocated to one treatment, and given 42 days to treat a single qualifying migraine attack of moderate to severe intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almotriptan | Experimental | Drug: Almotriptan 12.5 Mg Oral Tablet12.5 mg almotriptan taken orally once |
| Ubrogepant | Active comparator | Drug: Ubrogepant 50Mg Tab50 mg ubrogepant taken orally once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Aged 18 to 65 years upon entry into screening
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-3 criteria based on medical records and/or patient self-report.
- Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.
Key exclusion criteria (30 listed)
- Disease Related
- Greater than 50 years of age at migraine onset
- History of cluster headache or hemiplegic migraine headache
- Inability to differentiate between migraine from other headaches
- Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per months in the previous 3 months
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 |
|---|---|---|
| Almotriptan 12.5 Mg Oral TabletAlso: AlmogranTreatment for an acute, moderate to severe migraine attack | Drug | Almotriptan |
| Ubrogepant 50Mg TabAlso: UbrelvyTreatment for an acute, moderate to severe migraine attack | Drug | Ubrogepant |
Primary outcome
Pain freedom at 2 hours
Time frame: 2 hours after initial dose
Pain freedom will be subjectively rated by the patient in a headache diary (yes or no).
Results and safety
The study was stopped early (reason given: Issues with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- 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.
Messoud Ashina, Prof. principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Almotriptan 12.5 Mg Oral Tablet and Ubrogepant 50Mg Tab in people with Migraine With Aura and Migraine Without Aura, run by Messoud Ashina, MD at 1 site in Denmark.
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 4 inclusion and 30 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: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 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?
The study was stopped early (reason given: Issues with recruitment). 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 at 2 hours (time frame: 2 hours after initial dose). 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 31 May 2025.