Exploring Treatment Options for Children and Adolescents With Migraines

Please note: This trial has finished recruiting and is not accepting new participants.

Research Center:  Pacific Clinical Research Management Group
Location: 1317 W. Foothill Blvd., Suite #140 Upland, California 91786 
Lead Researcher: Jeffrey Ries, DO
IRB Committee: This study has been reviewed and approved by the Advarra Institutional Review Board

About the Study

Migraine is a debilitating headache disorder that can significantly impair the quality of life of children and adolescents. When both parents have a history of migraines, there is a 70% chance that the child will also develop migraines. During an attack, migraine sufferers often look ill and pale, feel dizzy, have blurred vision, and fever. Nausea, vomiting, and sensitivity to light are frequent, particularly in young children. More than half of children and adolescents with migraines have 1 to 4 attacks per month, disturbing their daily life activities.

Researchers are constantly finding ways to provide relief among children and adolescents who experience migraines. This research study seeks to determine the effectiveness of a potential treatment for migraine attacks in children and adolescents. 

Why Participate? 

  • Participants may receive a new potential treatment for migraines at no cost.
  • Participants may experience potential relief from their migraine symptoms. 
  • Participants will be contributing valuable information that may benefit other kids and teens with migraines in the future.
  • Participants and their whole family may learn more about migraines in general. The participant may also know more about his or her migraine pattern, associated symptoms, triggers, and risks.  
  • Reimbursement may be provided to eligible participants depending on the number of study visits they complete.
  • Participants will be helping to advance migraine treatment research.

Your Rights

  • If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
  • Any information that you provide will be kept strictly confidential, except as required by law.
  • Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

  • Children and adolescents aged 6-17 years old who have been experiencing migraines (with or without aura) for more than 6 months
    • This study requires parental or legal guardian consent to participate. 
  • Must have been experiencing 1-8 migraine attacks every month in the last 2 months 
    • Each attack should last more than 3 hours without treatment
  • Must be able to distinguish between migraines and other types of headaches
  • Must be either: 
    • On a stable dose of migraine medication 
    • Stopped taking migraine medication in the last 90 days
  • Must not have a cluster headache or a hemiplegic migraine headache
    • If the parent or the interested individual does not know what this means, the study team can further explain what a cluster headache or a hemiplegic migraine headache is 
  • Must be able to attend 4 study visits at the research site for up to 19 weeks

Key Study Details 

  • The potential treatment is thought to relieve migraine symptoms by reducing inflammation and pain signals to the brain. Participants must be able to swallow pills as a whole (the pills should not be cut).
  • Participants may get a placebo instead of the potential treatment. A placebo looks like the study treatment but does not contain any active ingredient found in the potential treatment. Researchers use a placebo to see if the study medication works better or is safer than taking nothing.
  • Participants will be asked to answer health questionnaires and assessments.

About the Research Center:

Pacific Clinical Research Management Group

Since 1987, Pacific Clinical Research Management Group has been an internationally recognized leader in clinical trial research. Their experienced, knowledgeable staff has treated thousands of patients throughout Los Angeles, Orange County and the Inland Empire. They are experts in the treatment of depression, anxiety disorders, ADHD, bipolar disorder, and other mental health disorders.

Please note:
Due to the current situation with the COVID-19 pandemic, the researchers would like to assure the participants that ensuring the safety of the participants as well as the study staff is of utmost importance.

What’s Next?

  1. Click the link to enter your contact details and take the study questionnaire.
  2. If eligible, a member of the research team will contact you to discuss the study and answer any questions you may have.
Click Here to Check Your Eligibility for This Study