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

NCT05214001 | Terminated Phase 4 FDA Drug

• 2 other identifiers: 2702212021-001087-24
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• Pain freedom at 2 hours

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

  2 hours after initial dose

Other Outcomes (9)

• Absence of the most bothersome symptom (MBS) at 2 hours

  2 hours after initial dose

• Relapse

  48 hours after initial dose

• Headache intensity

  Predose, and 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 hours after initial dose

Study Arms (2)

Almotriptan

EXPERIMENTAL

12.5 mg almotriptan taken orally once

Drug: Almotriptan 12.5 Mg Oral Tablet

Ubrogepant

ACTIVE COMPARATOR

50 mg ubrogepant taken orally once

Drug: Ubrogepant 50Mg Tab

Interventions

Almotriptan 12.5 Mg Oral Tablet DRUG

Treatment for an acute, moderate to severe migraine attack

Also known as: Almogran

Almotriptan

Ubrogepant 50Mg Tab DRUG

Treatment for an acute, moderate to severe migraine attack

Also known as: Ubrelvy

Ubrogepant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Messoud Ashina, MD: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura

Interventions

almotriptan; Tablets; ubrogepant

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Messoud Ashina, Prof.

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 28, 2022
• Study Start: June 30, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)