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

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ClinicalTrials.gov Identifier: NCT04965675
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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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
Chronic Migraine in Children Drug: Eptinezumab Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 30, 2021
Estimated Primary Completion Date : December 3, 2023
Estimated Study Completion Date : January 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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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 Name: 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 Name: 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
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Primary Outcome Measures :
  1. Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]

Secondary Outcome Measures :
  1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 [ Time Frame: Baseline up to Weeks 1-12 ]
  2. Percentage of Participants With Migraine on the Day After Dosing (Day 1) [ Time Frame: Day 1 ]
  3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 [ Time Frame: Baseline up to Weeks 1-12 ]
  5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 [ Time Frame: Baseline up to Weeks 1-4 ]
  6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 [ Time Frame: Baseline up to Weeks 1-4 ]
  7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  11. Free Eptinezumab Plasma Concentration [ Time Frame: 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]) [ Time Frame: From randomization (Week 0) up to Week 20 ]
  13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) [ Time Frame: From randomization (Week 0) up to Week 20 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965675


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S H. Lundbeck A/S
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04965675    
Other Study ID Numbers: 19356A
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases