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Galcanezumab + BMPT for Migraine (TOGETHER Trial)
TOGETHER Trial Summary
This trial studies if adding Galcanezumab to Botox + another migraine medicine helps reduce migraine days for people ages 18-65 with persistent unmet need.
- Migraine
TOGETHER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TOGETHER Trial Design
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Who is running the clinical trial?
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- You have received nerve blocks or trigger point injections in the past 8 weeks or plan to receive them during the study.You have had a bad reaction to other medications similar to galcanezumab injections in the past.You have experienced daily headaches in the month leading up to the screening.You have a history of substance abuse or addiction, as determined by the investigator.You have experienced a significant decrease (more than 30%) in the number of migraine days per month after starting Botox treatment.You have more than 6 migraine days in a month and less than 25 days of head pain during the baseline period.You have experienced migraines before you turned 50 years old.You are able to tell the difference between migraine headaches and other types of headaches like tension headaches.You are taking more than one medication, in addition to onabotulinumtoxinA, to prevent migraines within the past 12 weeks or during the study.You experience more than 6 migraine days per month, even after trying at least 2 and up to 8 rounds of onabotulinumtoxinA treatment. This is based on the guidelines for diagnosing migraines.
- Group 1: Placebo + BMPT
- Group 2: Galcanezumab + BMPT
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Does this trial include participants who are octogenarians?
"This medical research is available to individuals aged 18 or above and 65 or below."
Has the combination of Galcanezumab and BMPT attained regulatory acceptance?
"Our team assessed the safety profile of Galcanezumab + BMPT and gave it a score of 3 since Phase 4 clinical trials have already affirmed its approval."
Are there any slots vacant for this research investigation?
"Current data hosted on clinicaltrials.gov does not indicate that this medical trial is recruiting patients at present, as the last update was made on February 14th 2023. Despite this, there are 222 other studies actively seeking participants right now."
What are the prerequisites for participating in this experiment?
"This clinical trial seeks 150 individuals with migraines aged 18 to 65. To qualify, candidates must fulfil the following criteria: be within the aforementioned age range at time of Visit 1; have a minimum of 6 migraine days per month after 2-8 consecutive treatments of onabotulinumtoxinA; report >30% decrease in monthly migraine days since starting treatment with Botox (onabotulinumtoxinA); score over 11 on MIDAS questionaire; experience <25 days/month headache pain prior to baseline period and onset before 50th birthday; distinguish between primary headaches such as tension type headache; agree to participate"
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