Austin Regional Clinic Physicians constantly tries to improve the care given to you and to all our patients. We are dedicated to offering unique options for our patients to help them reach ideal health goals. Part of this dedication involves making clinical research available. Clinical research makes it possible to discover the benefits, risks, and safety of both commercially-available and investigational medications.

Research standards are very strict to help make studies as safe as possible. Each study we conduct has already been reviewed by teams of government and research experts to minimize any study risks. Austin Regional Clinic has decided to be involved in this research study because we think it can potentially benefit our patients. 

About Study

ARC will recruit patients from across Central Texas to enroll in this late phase clinical trial nicknamed “PIONEER-PEDS1.” This study intends to look at an investigational medication called Lasmiditan in reducing the pain of migraine headaches in children and adolescents.

Migraine is a common neurological disorder in pediatrics. Migraine attacks are characterized by intense pain and associated symptoms. Adult and pediatric migraine symptoms can include dull or throbbing pain, sensitivity to noise or light, nausea and vomiting, and irritability. Pediatric migraines can differ from adults and have pain located in different areas, have shorter attacks, and reduced ability to describe associated symptoms. This can lead to missed school days and worsened academic performance.

There are few options approved for adolescents to help the acute treatment of migraine. Only 1 treatment is approved for children aged 6 to 11 years, this study is being conducted to meet the need for more options for adolescents with migraines. This is a research study of an oral investigational medication for children and adolescents ages 6 to less than 18 who have a history of migraine attacks. Patients will be randomized to receive either the investigational medication or a placebo.

If you suffer from the following types of migraines, you might be a canidate for this study.

  • Chronic migraine
  • Episodic migraine (EM)
  • Migraine with aura (MWA)
  • Migraine without aura (MWOA)

If you’d like to see if you qualify, please contact our research team. You can call our ARC Clinical Research team at 512-225-5931, or fill out our Clinical Research interest form online.

What to Expect

Study is to evaluate the safety and effectiveness of an investigational medication called lasmiditan in reducing the pain of migraine headaches in children and adolescents.

Eligibility Criteria:

  • Patient is male or female and at least 6 and less than 18 years of age at Screening
  • Patient must have a minimum body weight of 15 kg
  • Patient has a history of migraine with or without aura and meets the following criteria:
    • History of migraine attacks for more than 6 months
    • Reports at least 2 and no more than 8 moderate to severe migraine attacks per month in the 2 months prior to the Screening Visit
    • Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
    • Patient has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the study team
  •  Patient must be able to swallow a tablet
    • For patients taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1
    • The patient and patient’s parent or guardian are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Key exclusion criteria:*

    • Patient has a history or clinical evidence of congenital heart disease, suspected or confirmed
    • ECG showing abnormalities compatible with acute cardiovascular events, serious cardiovascular disease risk, or both
    • Within 6 months of Screening, patient has had
      • Myocardial infarction
      • Unstable angina
      • Percutaneous coronary intervention, and
      • Coronary artery bypass graft
    • Patient is pregnant or breastfeeding

    *Additional eligibility requirements may apply.

Locations: 

# Visit's Required: 

  • 20 weeks long
    • 3 visits required

Request to Participate