Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

  • STATUS
    Recruiting
  • End date
    Jun 21, 2022
  • participants needed
    300
  • sponsor
    Allergan
Updated on 19 September 2021
Investigator
Clinical Trials Registry Team
Primary Contact
Aggarwal and Associates Limited (2.4 mi away) Contact
+134 other location

Summary

This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in episodic migraines in participants who previously failed 2 to 4 classes of oral prophylactic treatments.

Details
Condition Episodic Migraine
Treatment Placebo, Atogepant 60 mg
Clinical Study IdentifierNCT04740827
SponsorAllergan
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018
Age of the participant at the time of migraine onset < 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
to 14 migraine days in the 28-day baseline period per eDiary
Failed oral migraine prophylaxis medications from 2 to 4 medication classes

Exclusion Criteria

Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
Has 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
Has 15 headache days in the 28-day baseline period per eDiary
Clinically significant cardiovascular or cerebrovascular disease
Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018
Clear my responses

How to participate?

Step 1 Connect with a site
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.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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

Learn more

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.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note