Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17years) for the preventive treatment of chronic migraine.

Conditions

Migraine

Brief summary

"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "

Detailed description

Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12, Percentage of Participants With Migraine on the Day After Dosing (Day 1), Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12, Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12, Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4, Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4, Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12, Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12, Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12, Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12, Free Eptinezumab Plasma Concentration, Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]), Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

Related papers

No related papers found yet.

Interventions

DRUGVYEPTI 100 mg concentrate for solution for infusion

DRUGNacl 0.9%

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "	—

Secondary

Measure	Time frame
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12, Percentage of Participants With Migraine on the Day After Dosing (Day 1), Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12, Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12, Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4, Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4, Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12, Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12, Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12, Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12, Free Eptinezumab Plasma Concentration, Number of Participants With Specific Anti-Eptinezumab An	—

Measure

Time frame

Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12, Percentage of Participants With Migraine on the Day After Dosing (Day 1), Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12, Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12, Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4, Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4, Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12, Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12, Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12, Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12, Free Eptinezumab Plasma Concentration, Number of Participants With Specific Anti-Eptinezumab An

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Countries

Italy, Poland, Portugal, Spain

Outcome results

None listed