Zavegepant (nasal spray) for treating migraine in children 6 to under 12

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, open-label trial gives a single intranasal dose of zavegepant to children with a history of migraine and measures blood levels over time and any side effects. Dosing is determined by the child’s weight, and participants will be followed for safety and pharmacokinetic sampling. The study includes three clinic visits over about 10 weeks to collect safety data and samples to understand how the drug is absorbed, distributed, metabolized, and cleared. Children with recent continuous migraine, significant medical or uncontrolled psychiatric conditions, certain liver test abnormalities, or issues affecting nasal drug delivery are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants aged 6 years to less than 12 years.
2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
3. Weight \>15 kg at the Screening Visit

Exclusion Criteria:

1. Evidence or history of clinically significant disease.
2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
4. Conditions that may affect the administration or absorption of the nasal product
5. Any psychiatric condition that is uncontrolled and/or untreated, including:

   * Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)
   * Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours)
6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
7. Abnormal ECG (Electrocardiogram) at screening visit

Where it's running

• Velocity Clinical Research, Washington DC
  Washington D.C., District of Columbia, United States Recruiting
• Coastal Heritage Clinical Research
  Hinesville, Georgia, United States Recruiting
• Clinical Research Institute
  Minneapolis, Minnesota, United States Recruiting
• Children's Hospital & Medical Center
  Omaha, Nebraska, United States Recruiting
• True North Neurology
  Port Jefferson Station, New York, United States Recruiting
• Accellacare - Piedmont
  Statesville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rimegepant 75 mg ODT for acute migraine in adults in India

  A single-arm study in adults in India will test whether a 75 mg orally disintegrating tablet of rimegepant is safe to use for treating a migraine attack when triptans didn’t work or can’t be used.

  Recruiting at 6 sites Phase 4 Pfizer · Visakhapatnam, Andhra Pradesh and 6 other locations · NCT07685769

• Second dose of rimegepant for acute migraine in adults

  This study tests whether taking a second 75 mg dose of rimegepant is safe and tolerable for adults who still have pain after an initial dose to treat an acute migraine attack.

  Recruiting at 19 sites Phase 4 Pfizer · Canoga Park, California and 23 other locations · NCT07609914

• Long-term safety of rimegepant for treating migraines in children

  This study is testing the long-term safety of rimegepant, a migraine medication, for children and teens aged 6 to under 18 who have frequent migraine attacks.

  Recruiting at 61 sites Phase 3 Pfizer · Scottsdale, Arizona and 123 other locations · NCT04743141

• Daily rimegepant for chronic migraine prevention

  A 12-week test to see if taking rimegepant by mouth every day can reduce monthly migraine days in adults with chronic migraine compared with placebo.

  Recruiting at 18 sites Phase 3 Pfizer · Scottsdale, Arizona and 20 other locations · NCT07729462

• Long-term safety test of elismetrep for acute migraine

  This study tests whether intermittent use of elismetrep is safe and tolerable over the long term for people who have migraine attacks.

  Recruiting at 113 sites Phase 3 TriGemX Bio, Inc. · Birmingham, Alabama and 112 other locations · NCT07674654

• Gepants for Acute Migraine in the Emergency Department

  This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.

  Recruiting Phase 1 University of South Florida · Tampa, Florida · NCT07667621

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.