Interventional, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine

Conditions

Migraine

Brief summary

Changes from baseline in the number of monthly migraine days (MMDs) averaged over weeks 1-12

Detailed description

1. Response: ≥50% reduction from baseline in MMDs 2. Percentage of participants with migraine on the day after dosing (Day 1) 3. Change from baseline in MMDs with acute medication use 4. Response: ≥75% reduction from baseline in MMDs 5. Change from baseline in the number of Monthly Headache Days (MHDs), 6. Change from baseline in monthly hours with headache 7. Change from baseline in days with acute medication 8. Change from baseline in rate of migraines with severe pain intensity 9. Change from baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) score, 11.Free eptinezumab plasma concentrations 12. Number of participants with specific anti-eptinezumab antibodies (Anti-Drug Antibodies [ADA]) Number of participants with specific ADA-positive samples for Neutralizing Antibodies (NAb)

Related papers

No related papers found yet.

Interventions

DRUGNaCl 0.9%

DRUGVYEPTI 100 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Changes from baseline in the number of monthly migraine days (MMDs) averaged over weeks 1-12	—

Secondary

Measure	Time frame
1. Response: ≥50% reduction from baseline in MMDs 2. Percentage of participants with migraine on the day after dosing (Day 1) 3. Change from baseline in MMDs with acute medication use 4. Response: ≥75% reduction from baseline in MMDs 5. Change from baseline in the number of Monthly Headache Days (MHDs), 6. Change from baseline in monthly hours with headache 7. Change from baseline in days with acute medication 8. Change from baseline in rate of migraines with severe pain intensity 9. Change from baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) score, 11.Free eptinezumab plasma concentrations 12. Number of participants with specific anti-eptinezumab antibodies (Anti-Drug Antibodies [ADA]) Number of participants with specific ADA-positive samples for Neutralizing Antibodies (NAb)	—

Measure

Time frame

1. Response: ≥50% reduction from baseline in MMDs 2. Percentage of participants with migraine on the day after dosing (Day 1) 3. Change from baseline in MMDs with acute medication use 4. Response: ≥75% reduction from baseline in MMDs 5. Change from baseline in the number of Monthly Headache Days (MHDs), 6. Change from baseline in monthly hours with headache 7. Change from baseline in days with acute medication 8. Change from baseline in rate of migraines with severe pain intensity 9. Change from baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) score, 11.Free eptinezumab plasma concentrations 12. Number of participants with specific anti-eptinezumab antibodies (Anti-Drug Antibodies [ADA]) Number of participants with specific ADA-positive samples for Neutralizing Antibodies (NAb)

—

Countries

Italy, Poland, Portugal, Spain

Outcome results

None listed