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PROSPECT-2: A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04965675
Collaborator
(none)
285
Enrollment
16
Locations
3
Arms
30.9
Anticipated Duration (Months)
17.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Dec 3, 2023
Anticipated Study Completion Date :
Jan 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eptinezumab 300 mg

Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).

Drug: Eptinezumab
Eptinezumab will be administered per dose and schedule specified in the arm.
Other Names:
  • Vyepti

    		•
    Experimental: Eptinezumab 100 mg

    Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

    Drug: Eptinezumab
    Eptinezumab will be administered per dose and schedule specified in the arm.
    Other Names:
  • Vyepti

    		•
    Placebo Comparator: Placebo

    Participants will receive a single IV infusion of placebo matching to eptinezumab.

    Drug: Placebo
    Placebo matching to eptinezumab will be administered per schedule specified in the arm.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

    Secondary Outcome Measures

    1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 [Baseline up to Weeks 1-12]

    2. Percentage of Participants With Migraine on the Day After Dosing (Day 1) [Day 1]

    3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

    4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 [Baseline up to Weeks 1-12]

    5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 [Baseline up to Weeks 1-4]

    6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 [Baseline up to Weeks 1-4]

    7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

    8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

    9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

    10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

    11. Free Eptinezumab Plasma Concentration [Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)]

    12. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [From randomization (Week 0) up to Week 20]

    13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) [From randomization (Week 0) up to Week 20]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.

    • During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 24 of the 28 days following the screening visit.

    • During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

    Exclusion Criteria:

    • The participant has previously been enrolled in this study and exposed to eptinezumab.

    • The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.

    • The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.

    • The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), 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), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A G A Clinical Trials - HyperCore - PPDS Hialeah Florida United States 33012-3407
    2 Axcess Medical Research Loxahatchee Groves Florida United States 33470-9272
    3 University of Kentucky HealthCare (UKHC) Kentucky Clinic Lexington Kentucky United States 40508-1683
    4 Michigan Head Pain and Neurological Institute Ann Arbor Michigan United States 48104-5131
    5 Dent Neurosciences Research Center Incorporated Amherst New York United States 14226-1746
    6 OnSite Clinical Solutions, LLC - ClinEdge - PPDS Charlotte North Carolina United States 28226-8371
    7 Children's Specialty Group Norfolk Virginia United States 23510-1021
    8 Mary Bridge Children's Hospital Tacoma Washington United States 98405-4048
    9 Hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires Ciudad Autonoma De BuenosAires Argentina C1181ACH
    10 Expertia S.A- Mautalen Salud e Investigacion Ciudad Autonoma de Buenos Aires Ciudad Autonoma De BuenosAires Argentina C1128AAF
    11 Sanatorio Allende S.A. Ciudad De Cordoba Cordoba Argentina X5000JHGQ
    12 Hospital de Niños de La Santisima Trinidad Cordoba-Barrio Crisol Cordoba Argentina X5014AKM
    13 Centro de Investigaciones Médicas Tucuman San Miguel de Tucuman Tucuman Argentina T4000AXL
    14 The Kids Clinic Ajax Ontario Canada L1Z 0M1
    15 Hospital Universitario Vall d'Hebron - PPDS Barcelona Spain 8025
    16 Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain 46026

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

    • Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT04965675
    Other Study ID Numbers:
    • 19356A
    First Posted:
    Jul 16, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Aug 18, 2022