A Phase 3, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Atogepant For The Prevention Of Chronic Migraine (PROGRESS)

Updated on 3 August 2020


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.


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.


Condition Migraine (Adult), Migraine and Cluster Headaches
Clinical Study IdentifierTX249638
Last Modified on3 August 2020


Yes No Not Sure

Inclusion Criteria

At least 1-year history of migraine with or without aura
History of, on average, >15 headache days per month, and >8 days that qualify as being a migraine day
Cannot be currently taking a migraine preventative medication
Cannot be a user of recreational or illicit drugs, including CBD products (there will be a drug screening at screening)
Cannot have previous exposure to injectable monoclonal antibodies blocking the CGRP pathway within the last 6 months
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If 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.

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Complete 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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