- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05214001
Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM)
A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Glostrup, Denmark, 2600
- Recruiting
- Danish Headache Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Almotriptan
12.5 mg almotriptan taken orally once
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Treatment for an acute, moderate to severe migraine attack
Other Names:
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ACTIVE_COMPARATOR: Ubrogepant
50 mg ubrogepant taken orally once
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Treatment for an acute, moderate to severe migraine attack
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain freedom at 2 hours
Time Frame: 2 hours after initial dose
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Pain freedom will be subjectively rated by the patient in a headache diary (yes or no).
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2 hours after initial dose
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache intensity
Time Frame: Predose, and 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 hours after initial dose
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Headache intensity will be subjectively rated by the patient at predefined timepoints on a 4-point scale where 0 = no headache; 1 = mild headache; 2 = moderate headache; 3 = severe headache.
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Predose, and 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 hours after initial dose
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Absence of the most bothersome symptom (MBS) at 2 hours
Time Frame: 2 hours after initial dose
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Patients are to select their MBS prior to randomization, and then only treat an attack that occurs with the pre-specified MBS. 2 hours after initial dose, patients are to subjectively rate if the MBS have disappeared fully or if it is still present (present or not present).
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2 hours after initial dose
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Relapse
Time Frame: 48 hours after initial dose
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Patients, who were pain free 2 hours after the investigational treatment was administered, are to subjectively evaluate if they experienced reoccurrence of headache of any severity within 48 hours of the intake of given treatment (relapse of headache or no headache).
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48 hours after initial dose
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Rescue medication
Time Frame: 48 hours after initial dose
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The patient will record if they take any rescue medication 2 hours after intake of test medication and within 48 hours.
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48 hours after initial dose
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Global evaluation
Time Frame: 48 hours after initial dose
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The patient will subjectively rate their global impression of the test medication based on Likert-type verbal scale (e.g., very poor, poor, no opinion, good, very good).
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48 hours after initial dose
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Associated symptom - nausea
Time Frame: Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
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The presence or absence of nausea.
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Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
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Associated symptom - photophobia
Time Frame: Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
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The presence or absence of photophobia.
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Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
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Associated symptom - phonophobia
Time Frame: Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
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The presence or absence of phonophobia.
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Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
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Adverse events
Time Frame: Up to 48 hours after initial dose.
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Any untowards medical events are to be recorded in the diary by the patients.
Furthermore, the patient will be instructed to inform the investigator in such case.
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Up to 48 hours after initial dose.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Migraine without Aura
- Migraine with Aura
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin Receptor Agonists
- Almotriptan
Other Study ID Numbers
- 270221
- 2021-001087-24 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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