Status:
TERMINATED
Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine
Lead Sponsor:
Messoud Ashina, MD
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 afte...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05214001
Start Date
June 30 2022
End Date
April 15 2024
Last Update
May 31 2025
Active Locations (1)
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1
Danish Headache Center
Glostrup Municipality, Denmark, 2600