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Monoclonal Antibodies
Eptinezumab for Pediatric Migraine (PROSPECT-1 Trial)
Phase 3
Recruiting
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (pre-dose) and at weeks 8, 12, and 20
Awards & highlights
PROSPECT-1 Trial Summary
This trial tests if a drug can reduce migraine days for kids with episodic migraines.
Who is the study for?
This trial is for kids with episodic migraines, diagnosed per international standards, who've had migraines for at least 6 months. They must have tracked their headaches in an eDiary during the screening period. It's not for those with severe head trauma, other major neurological disorders, unusual migraine types like hemiplegic migraine or if they have uncontrolled psychiatric conditions.Check my eligibility
What is being tested?
The study aims to find out if Eptinezumab can reduce the number of days children experience episodic migraines compared to a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Eptinezumab or the placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with migraine medications include reactions at the injection site, nausea, fatigue and allergic reactions. The exact side effects of Eptinezumab in children will be monitored throughout the trial.
PROSPECT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 (pre-dose) and at weeks 8, 12, and 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (pre-dose) and at weeks 8, 12, and 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Secondary outcome measures
Change From Baseline in Days with Acute Medication
Change From Baseline in MMDs with Acute Medication Use
Change From Baseline in Monthly Hours with Headache
+9 moreSide effects data
From 2020 Phase 3 trial • 485 Patients • NCT041520832%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eptinezumab
PROSPECT-1 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Eptinezumab 300 mgExperimental Treatment1 Intervention
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Group II: Eptinezumab 100 mgExperimental Treatment1 Intervention
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single IV infusion of matching placebo to eptinezumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
2021
Completed Phase 3
~2040
Find a Location
Who is running the clinical trial?
H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,268 Total Patients Enrolled
13 Trials studying Migraine
4,786 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
188 Previous Clinical Trials
58,025 Total Patients Enrolled
12 Trials studying Migraine
4,288 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mental health condition has been stable and treated for at least 6 months.I have been diagnosed with a specific type of severe or unusual headache.I have been diagnosed with migraines for at least 6 months.I've had 14 or fewer headache days, with at least 4 being migraines, in the last 28 days.I don't have any health issues that would interfere with the migraine study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Eptinezumab 300 mg
- Group 2: Placebo
- Group 3: Eptinezumab 100 mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor enlisting individuals aged 85 or above?
"According to the study's protocols, only individuals between 6 and 17 years of age are permissible for enrolment."
Answered by AI
To what extent is Eptinezumab 100 mg hazardous to people's health?
"Our team's evaluation of the safety of Eptinezumab 100 mg was a 3, due to evidence from previous trials signifying its efficacy and multiple rounds indicating security."
Answered by AI
Are there any open enrollment opportunities with this clinical trial?
"As observed on clinicaltrials.gov, this medical study is actively in search of participants. The trial launched on June 8th 2023 and underwent the latest amendment to its protocol on June 20th 2023."
Answered by AI
How many individuals have signed up to partake in this research project?
"Affirmative. Clinicaltrials.gov information verifies that this experiment, which was initially posted on June 8th 2023, is presently recruiting participants. 315 individuals must be enrolled from a single location."
Answered by AI
Which individuals are eligible to sign up for this research?
"Prospective candidates for this clinical investigation must be suffering from migraine and between the ages of 6 to 17. The trial is hoping to recruit a total of 315 participants."
Answered by AI
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