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Monoclonal Antibodies

Eptinezumab for Chronic Migraine in Adolescents (PROSPECT-2 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
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization ( pre-dose [week 0]), week 8, week 12, and safety follow up visit (week 20)
Awards & highlights

PROSPECT-2 Trial Summary

This trial is testing whether eptinezumab is better than placebo at reducing the number of days with migraine in young people with chronic migraine.

Who is the study for?
This trial is for adolescents aged 12-17 with chronic migraine, as defined by ICHD-3 guidelines. They must have had a history of migraines for at least 6 months and experienced ≥15 to ≤26 headache days during the screening period, with at least 8 being migraine days. Participants should not have used any monoclonal antibody or CGRP antibody treatments in the past 6 months.Check my eligibility
What is being tested?
The study aims to determine if Eptinezumab is more effective than a placebo (normal saline solution) in reducing the number of migraine days in young people with chronic migraines. It's a comparison between an active drug and an inactive substance.See study design
What are the potential side effects?
While specific side effects are not listed here, Eptinezumab may cause reactions similar to other monoclonal antibodies such as injection site reactions, potential allergic responses, fatigue, or flu-like symptoms.

PROSPECT-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic migraine for at least 6 months.

PROSPECT-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization ( pre-dose [week 0]), week 8, week 12, and safety follow up visit (week 20)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization ( pre-dose [week 0]), week 8, week 12, and safety follow up visit (week 20) for reporting.

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 Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Secondary outcome measures
Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
+10 more

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083
2%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eptinezumab

PROSPECT-2 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Eptinezumab 300 mgExperimental Treatment1 Intervention
Participants will receive a single 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 placebo matching 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
324 Previous Clinical Trials
77,290 Total Patients Enrolled
13 Trials studying Migraine
4,786 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,055 Total Patients Enrolled
12 Trials studying Migraine
4,288 Patients Enrolled for Migraine

Media Library

Eptinezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04965675 — Phase 3
Migraine Research Study Groups: Eptinezumab 300 mg, Eptinezumab 100 mg, Placebo
Migraine Clinical Trial 2023: Eptinezumab Highlights & Side Effects. Trial Name: NCT04965675 — Phase 3
Eptinezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04965675 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other similar trials to this one?

"Eptinezumab has been under investigation since 2020. The first set of tests were run in the same year and financed by H. Lundbeck A/S.. After the preliminary study with a sample size of 32 people, Eptinezumab received Phase 1 approval. As of now, there are 7 clinical trials involving this drug being conducted in 130 different cities across 25 countries."

Answered by AI

When will Eptinezumab be available for general medical use?

"Eptinezumab's safety is similar to that of other medications in its class, and it received a score of 3."

Answered by AI

Who would this clinical trial be suited for?

"This trial is designed for children and adolescents who suffer from sick headaches. The age limit to participate is 12-17 years old, and the team aims to enroll 285 patients in total."

Answered by AI

At how many hospitals is this clinical trial taking place?

"There are a total of 12 sites currently recruiting patients for this trial. Some notable locations include Ki Health Partners LLC DBA New England Institute for Clinical Research in Stamford, The University of Oklahoma Health Sciences Center in Oklahoma City, and Dent Neurosciences Research Center Incorporated in Amherst."

Answered by AI

Do patients have to be under a certain age to qualify for this test?

"The age requirement to participate in this clinical trial is 12-17 years old."

Answered by AI

Are patients being sought for this experiment currently?

"Yes, this is an ongoing study that was first posted on 6/30/2021 and updated as recently as 11/9/2022. They are looking for 285 people total at 12 different clinical trial sites."

Answered by AI

What other medical research studies has Eptinezumab been involved in?

"Eptinezumab was first studied in 2020 by the NW FL Clinical Research Group LLC (US0009). So far, there have been 18292 completed clinical trials and there are 7 active studies. A majority of these ongoing studies are based out of Stamford, Connecticut."

Answered by AI

What is the desired sample size for this research project?

"In order for this clinical trial to run as planned, the sponsor needs to recruit 285 eligible patients. The study will be conducted by H. Lundbeck A/S from various locations, two of which are Ki Health Partners LLC DBA New England Institute for Clinical Research in Stamford, Connecticut and The University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma."

Answered by AI
~50 spots leftby Oct 2024