Comparing Almotriptan and Ubrogepant for Treating Migraines

A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM).

This study is testing whether a 12.5 mg dose of almotriptan works better than a 50 mg dose of ubrogepant to help adults with migraines feel pain-free within two hours.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 645 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Danish Headache Center (other)
• Drugs / interventions: erenumab, fremanezumab, galcaneszumab
• Locations: 1 site (Glostrup)
• Trial ID: NCT05214001 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of 12.5 mg almotriptan compared to 50 mg ubrogepant in achieving pain freedom within two hours for adults experiencing migraines. It is a randomized, open-label, parallel-group study involving 645 participants who have a history of migraine with or without aura. Each participant will be assigned to one of the two treatments and will have 42 days to manage a single qualifying migraine attack of moderate to severe intensity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a history of migraine for at least 12 months and no more than 12 migraine attacks per month.

Not a fit: Patients with a history of cluster headaches, hemiplegic migraines, or those who cannot differentiate their migraines from other headache types may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with effective treatment options for acute migraine relief.

How similar studies have performed: Previous studies have shown promising results in treating migraines with similar medications, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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.
* 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.

Where this trial is running

Glostrup

• Danish Headache Center — Glostrup, Denmark (RECRUITING)

Study contacts

• Principal investigator: Messoud Ashina, Prof. — Danish Headache Center
• Study coordinator: Messoud Ashina, Prof.

Conditions: Migraine With Aura, Migraine Without Aura