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Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM)

Primary Purpose

Migraine With Aura, Migraine Without Aura

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Almotriptan 12.5 Mg Oral Tablet
Ubrogepant 50Mg Tab
Sponsored by
Messoud Ashina, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Headache CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Almotriptan

Ubrogepant

Arm Description

12.5 mg almotriptan taken orally once

50 mg ubrogepant taken orally once

Outcomes

Primary Outcome Measures

Pain freedom at 2 hours
Pain freedom will be subjectively rated by the patient in a headache diary (yes or no).

Secondary Outcome Measures

Full Information

First Posted
January 11, 2022
Last Updated
September 21, 2022
Sponsor
Messoud Ashina, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05214001
Brief Title
Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine
Acronym
ATOM
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Messoud Ashina, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
645 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Almotriptan
Arm Type
Experimental
Arm Description
12.5 mg almotriptan taken orally once
Arm Title
Ubrogepant
Arm Type
Active Comparator
Arm Description
50 mg ubrogepant taken orally once
Intervention Type
Drug
Intervention Name(s)
Almotriptan 12.5 Mg Oral Tablet
Other Intervention Name(s)
Almogran
Intervention Description
Treatment for an acute, moderate to severe migraine attack
Intervention Type
Drug
Intervention Name(s)
Ubrogepant 50Mg Tab
Other Intervention Name(s)
Ubrelvy
Intervention Description
Treatment for an acute, moderate to severe migraine attack
Primary Outcome Measure Information:
Title
Pain freedom at 2 hours
Description
Pain freedom will be subjectively rated by the patient in a headache diary (yes or no).
Time Frame
2 hours after initial dose
Other Pre-specified Outcome Measures:
Title
Absence of the most bothersome symptom (MBS) at 2 hours
Description
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).
Time Frame
2 hours after initial dose
Title
Relapse
Description
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).
Time Frame
48 hours after initial dose
Title
Headache intensity
Description
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.
Time Frame
Predose, and 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 hours after initial dose
Title
Rescue medication
Description
The patient will record if they take any rescue medication 2 hours after intake of test medication and within 48 hours.
Time Frame
48 hours after initial dose
Title
Global evaluation
Description
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).
Time Frame
48 hours after initial dose
Title
Associated symptom - nausea
Description
The presence or absence of nausea.
Time Frame
Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
Title
Associated symptom - photophobia
Description
The presence or absence of photophobia.
Time Frame
Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
Title
Associated symptom - phonophobia
Description
The presence or absence of phonophobia.
Time Frame
Predose, 2, 4, 8, 12, 24- and 48-hours after initial dose
Title
Adverse events
Description
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.
Time Frame
Up to 48 hours after initial dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Messoud Ashina, Prof.
Phone
004538633385
Email
messoud.ashina@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, Prof.
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, Prof.
Phone
004538633385
Email
messoud.ashina@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine

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