At a glance
ClinicalIndex Comparison Record- ✓At least 1-year history of migraine with or without aura consistent with ICHD-3 2018 diagnosis
- ✓4 to 14 migraine days per month on average in the 3 months prior to screening
- ✕Clinically significant hematologic disease
- ✕Clinically significant cardiovascular disease
- ✕Clinically significant cerebrovascular disease
- ✕Clinically significant renal or hepatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Atogepant and Ubrogepant for Episodic Migraine. Completed, enrolled 263 participants across 37 sites.
Detailed Summary
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 migraine. 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.
Study Details
Timeline
Interventions
Oral Tablet
Oral Tablet