Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Migraines With Or Without Aura
• Age: Between 6 Year(s) - 18 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Must be able to provide signed written informed consent
  2. Participants must be able to read and comprehend written instructions and be willing to complete all questionnaires under supervision of legal representative(s) as required by the protocol.
  3. History of migraine (with or without aura) for =6 months before Screening
  4. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment
  5. Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study
  6. Participants are required to verbally distinguish between migraine and other types of headaches
  7. Participants must have a weight = 40 kg (child cohort weight requirement = 15 kg) at the Screening Visit
  8. Participants must have adequate venous access for blood sampling
  9. The participant, if a female who is sexually active and of childbearing potential (defined as females who have experienced menarche), or a male who is sexually active, must be willing to use acceptable methods of contraception
  10. Female participants must have confirmed negative serum and urine pregnancy test
  11. Not breastfeeding
  12. No clinically significant abnormality identified on the medical or laboratory evaluation.

  
  

You may not be eligible for this study if the following are true:

• 1. Participants have history of cluster headache or hemiplegic migraine headache.
  2. Have continuous migraine (defined as an unrelenting headache) during within 1 month prior to Screening Visit
  3. Participants have history or diagnosis of persistent aura without infarction, migrainous infarction, migraine aura-triggered seizure, chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
  4. Have confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study
  5. Any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit
  6. History of suicidal behavior or the participant is at risk of self-harm or harm to others
  7. History of major psychiatric disorder
  8. Have a current diagnosis or history of substance abuse
  9. History of cancer
  10. Have any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or safety assessments
  11. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator’s opinion, likely to affect central nervous system functioning
  12. Had recent or planned surgery, requiring general anesthesia
  13. Have or have had one of the following conditions that is/are considered clinically relevant in the context of the study:
      • Uncontrolled hypertension
      • Cardiovascular disease
      • Cardiomyopathy
      • Serious heart rhythm abnormalities
      • Cerebrovascular disease (for example CNS Vascular ischemia)
      • Thromboembolic event
      • Diabetes
      • Raynaud’s disease
      • Life-threatening allergy (for example anaphylaxis)
  14. Have had gastrointestinal surgery that interferes with physiological absorption and motility
  15. Have one or more clinically significant out-of-range vital signs at the Screening or Baseline Visit
  16. Have current diagnosis of viral hepatitis or a history of liver disease
  17. Have known history of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus (HIV)
  18. Have a history of severe drug allergy or hypersensitivity or known hypersensitivity or intolerance to the excipients in rimegepant