A Phase 3, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Atogepant For The Prevention Of Chronic Migraine (PROGRESS)
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- STATUS
- Recruiting
Summary
This is a 20-week study to evaluate the efficacy, safety, and tolerability of once-daily oral Atogepant for the prevention of migraine in participants with episodic migraine. Treatment groups include 30mg twice daily, 60mg once daily, and placebo.
This study will consist of a 4-week screening and baseline period, a 12-week double-blind treatment period, and a 4-week follow-up period, with the option of rolling into a long term open label study at study conclusion.
Description
There will be 8 scheduled clinic visits:
- Visit 1 (screening/basline)
- Visit 2 (Randomization/Day 0)
- Visit 3 (Week 2)
- Visit 4 (Week 4)
- Visit 5 (Week 6)
- Visit 6 (Week 8)
- Visit 7 (Week 12)
- Visit 8 (Follow up/rollover to long-term safety study)
Participants will receive $75 per visit with an additional $25 per visit for participating in an optional PK study.
Details
| Condition | Migraine (Adult), Migraine and Cluster Headaches |
|---|---|
| Clinical Study Identifier | TX249638 |
| Last Modified on | 3 August 2020 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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