Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Summary

This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Timeline

Start

2022-09-06

Primary completion

2024-09

Completion

2024-11

Publications

• Background Dodick DW, Lipton RB, Ailani J, Halker Singh RB, Shewale AR, Zhao S, Trugman JM, Yu SY, Viswanathan HN. Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II. Headache. 2020 Apr;60(4):686-700. doi: 10.1111/head.13766. Epub 2020 Feb 19.

Drugs

Indications