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Fremanezumab for Migraine
Study Summary
This trial will tell us if fremanezumab prevents migraine and improves sleep quality in people who suffer from migraines.
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.Trial Design
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- You have a history of feeling very scared in small, enclosed spaces.I have been diagnosed with migraine, following official guidelines.I am currently taking prescription pain medication for headaches or body pain.I agree not to change my preventive medications unless it's for migraines.I have had a stroke, TIA, or surgery on the arteries in my neck.I have a history of or suspect I have secondary headaches.I have used marijuana or CBD oil in the past year.I use medication to help me sleep every day.I am between 18 and 65 years old.Your recent ECG showed abnormal heart rhythms or patterns.I score 10 or higher on the Insomnia Severity Index.I have had a nerve block in my head or neck in the last 3 months.Your blood pressure is consistently very high, even after multiple measurements within a day.I have been diagnosed with obstructive sleep apnea or restless legs syndrome.I have been diagnosed with migraine, following specific guidelines.I have had botulinum toxin or anti-CGRP injections in the past 6 months.You have a body mass index (BMI) of 30 or higher.I am currently taking medication to prevent migraines.I do not have other major pain issues that could affect the study's results.I do not have severe heart problems like heart failure or a past heart attack.I regularly take painkillers or specific headache medicines more than half the month.I have 10-25 headache days a month, with at least 8 being long-lasting migraines.My migraines started when I was 50 or younger.
- Group 1: treatment effect
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is this treatment procedure viable for individuals in terms of safety?
"After a thorough assessment, our team at Power awarded this therapy a score of 3 due to it being in the final phase of clinical trials and its eventual approval."
How many participants are involved in this trial?
"That is correct. Clinicaltrials.gov attests to this medical trial's active recruitment process, which was launched on July 29th 2021 and recently modified March 16th 2022. The study seeks 100 participants from a single location."
Is this the inaugural instance of such a trial?
"At present, 4 trials are in action across 44 cities and 9 countries. This treatment first began to be trialed during 2020 by Teva Branded Pharmaceutical Products R&D, Inc., with 288 participants entering Phase 3 drug approval stage. Since then, 14 additional clinical studies have been conducted."
Are there any open opportunities for individuals to partake in this research?
"Current data on clinicaltrials.gov attests to this trial's ongoing search for participants. It was initially posted July 29th 2021 and its information has been kept up-to-date since March 16th 2022."
Is it possible for me to partake in this experiment?
"This medical trial seeks 100 individuals between 18-65 years of age who were diagnosed with sick headache in accordance to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), and have experienced up to 25 days of migraine per month during the last three months. Furthermore, applicants must score 10 or more on the Insomnia Severity Index; agree not switch any existing prophylactic medications that may interfere with study objectives (e.g., antidepressants); be able to give written consent; and present a history of migraines prior to 50 years old."
Is this examination accommodating seniors aged 70 and above?
"To be eligible to participate in this study, individuals must have surpassed the age of majority but not yet reached 65 years old."
What other medical experiments have been done using this therapeutic approach?
"Currently, there are 4 active studies related to this particular treatment. Three of these investigations have reached Phase 3 in the trial process, with a majority based in Dresden, Illinois and 241 other sites worldwide conducting research as well."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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