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Fremanezumab for Preventing Migraine in Children and Adolescents
Study Summary
This trial is testing the long-term safety and effectiveness of a drug to prevent migraines in children 6-17 years old. The trial will last up to 60 months.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 353 Patients • NCT04041284Trial Design
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Who is running the clinical trial?
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- If you were part of the earlier study, you cannot have any major health problems related to the heart, hormones, stomach, urinary system, blood, liver, immune system, nervous system, eyes, lungs, or kidneys, or any severe infections.I have never had a hemiplegic migraine.I haven't had a live vaccine in the last 12 weeks.If you were in another study before, you should not have had any serious mental health issues or thoughts of harming yourself in the past 2 years.I have no history of severe allergic reactions to proteins or specific skin conditions, and I'm not taking lamotrigine.I don't have HIV, TB, Lyme disease, hepatitis B or C, and I'm not currently infected with COVID-19.If you were part of the main studies, you should not have any important abnormal results on your baseline heart test, as decided by the doctor.I have received all vaccines recommended for my age as per local guidelines.I have not had allergic reactions to injected proteins, Stevens-Johnson Syndrome, toxic epidermal necrolysis, or used lamotrigine.If you were in the previous study (TV48125-CNS-10141), you should not have any important heart problems found in the baseline ECG.I don't have ongoing infections or a history of HIV, TB, Lyme disease, hepatitis B/C, or active COVID-19.I haven't had a live vaccine in the last 12 weeks.I weigh at least 17.0 kg and am enrolling from a previous study.I have received all vaccines recommended for my age.If you were in the previous study, you should not have a serious psychiatric condition, attempted suicide before, or had thoughts of ending your life with a plan in the past 2 years, as decided by the doctor.I weigh at least 17.0 kg and am moving from a previous study.I have not had hemiplegic migraines and am coming from a specific study.I was part of a previous study and am continuing the same medication.My BMI is between the 5th and 120% of the 95th percentile.
- Group 1: Fremanezumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 any vacancies in this research program for willing participants?
"That is correct. The clinicaltrials.gov website has the latest information on this study, which was created on September 16th 2020 and edited August 23rd 2022. There are 21 sites enrolling 550 patients in total."
At how many different sites can patients participate in this clinical trial?
"There are 21 enrolment sites for this trial, which are situated in major cities such as Minneapolis, Ottawa and Austin. To reduce the amount of travel required, patients are encouraged to enroll at the nearest location."
Does this clinical trial explore novel territory?
"Fremanezumab has been studied since 2020. The first study was completed in 2020 and was sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Following the first study in 2020, which involved 288 participants, Fremanezumab received its Phase 3 drug approval. Today there are 4 active studies for Fremanezumab across 44 cities and 9 countries."
For which patient population is this research opportunity open?
"This trial is looking for 550 participants, aged 6-17, who suffer from migraines. In addition to this, the following criteria must be met: The participant must weigh at least 17.0 kg on the day of enrollment, have completed a previous study related to efficacy, and in the opinion of the Sponsor or Investigator, be able to complete the current study safely., Participants may continue taking a stable dose/regimen of preventive medication that they were taking during the pivotal efficacy studies., The participant continues to meet appropriate criteria carried forward from the pivotal efficacy study/, The participant has received all recommended age-appropriate vaccines according to"
Does this medical research include elderly participants?
"The age requirements to participate in this trial are 6 years or older but younger than 17."
How many people can sign up for this research project?
"In order to run this experiment, the pharmaceutical company sponsoring it, Teva Branded Pharmaceutical Products R&D, Inc., needs to recruit 550 patients that meet the inclusion criteria from multiple clinical sites. For instance, potential participants can be recruited from Teva Investigational Site 14270 in Minneapolis or Teva Investigational Site 11179 in Ottawa."
What is the frequency of adverse effects associated with Fremanezumab?
"There is some evidence efficacy as well as numerous reports of safety, so Fremanezumab was given a 3."
What other drugs have been studied in combination with Fremanezumab?
"Currently, there are 4 ongoing clinical trials evaluating the efficacy of Fremanezumab. Most of these studies are Phase 3 investigations, with 241 total trial locations around the world. The majority of these medical centres conducting research on Fremanezumab are based in Dresden, Illinois."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
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How many prior treatments have patients received?
Why did patients apply to this trial?
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