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Eptinezumab for Chronic Migraine in Adolescents (PROSPECT-2 Trial)
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.
PROSPECT-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROSPECT-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 485 Patients • NCT04152083PROSPECT-2 Trial Design
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Who is running the clinical trial?
Media Library
- I have a history of severe or unusual types of headaches.I have been part of this study before and received eptinezumab.I haven't had any monoclonal antibody treatment in the last 6 months.I have been diagnosed with chronic migraine for at least 6 months.I've had 15 to 26 headache days, with at least 8 being migraines, in the last 28 days.I have not used any CGRP antibody treatments in the last 6 months.
- Group 1: Eptinezumab 300 mg
- Group 2: Eptinezumab 100 mg
- Group 3: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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."
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."
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."
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."
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