Clinical trial

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of Episodic Migraine

Name

M23-072

Description

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of EM. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Trial arms

Trial start

2022-03-07

Estimated PCD

2023-04-04

Trial end

2023-04-04

Status

Completed

Phase

Early phase I

Treatment

Atogepant

Oral Tablet

Arms:

Atogepant + Ubrogepant

Other names:

QULIPTA

Ubrogepant

Oral Tablet

Arms:

Atogepant + Ubrogepant

Other names:

UBRELVY

Size

263

Primary endpoint

Number of Participants With Adverse Events (AEs)

Up to approximately 28 weeks

Percentage of Participants With Clinically Significant Change in Laboratory Values as assessed by the Investigator

Up to approximately 28 weeks

Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator

Up to approximately 24 weeks

Percentage of Participants With Clinically Significant Change in Vital Sign Measurements as assessed by the Investigator

Up to approximately 28 weeks

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

Up to approximately 28 weeks

Eligibility criteria

Inclusion Criteria: * At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018. * History of 4 to 14 migraine days per month on average in the 3 months prior to Screening (Visit 1) in the investigator's judgment. Exclusion Criteria: - Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 263, 'type': 'ACTUAL'}}

Updated at

2023-04-07

1 organization

2 products

1 indication

Product

Indication

Product

Organization