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Lidocaine Hydrochloride 2 mg/mL Injectable Solution for Migraine
Study Summary
This trial is testing whether a nerve block can help with migraines in children and adolescents, and if lidocaine can help with the pain while maintaining blinding.
- Migraine
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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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Who is running the clinical trial?
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- You had a bad reaction or experienced problems after getting a shot or undergoing a medical procedure before.You have recently developed physical or neurological problems that were not present before.You are allergic to local numbing medicines.You have been diagnosed with frequent migraines that last up to 3 months and do not respond to typical headache medications. You can participate even if you didn't use those medications because they haven't helped you in the past.You have recent changes in your headache history that may require further investigation for underlying causes.
- Group 1: Greater Occipital Nerve (GON) Block with Saline
- Group 2: Greater Occipital Nerve (GON) Block with Lidocaine
- 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 trial open to people who are under 40 years of age?
"According to the inclusion criteria, the age range for this trial is 7-21. There are a total of 70 studies that have been conducted with people under 18 and 370 with patients over 65."
How can I sign-up to help with this research project?
"This migraine study is looking for 58 participants aged 7-21. The ideal candidate meets the following conditions: a diagnosis of episodic or chronic migraines with an acute headache that lasts up to 3 months and is unresponsive to medications, male or female, any gender, race, or ethnicity, weight >25kg. Children must provide assent to participate."
What is the frequency of Lidocaine Hydrochloride 2 mg/mL Injectable Solution in medical research?
"There are currently 235 live clinical trials studying Lidocaine Hydrochloride 2 mg/mL Injectable Solution, with 60 of those trials in Phase 3. Most of the clinical trials for this medication are based in Duarte, California; however, there are 1,471 locations around the world where these kind of studies are taking place."
What are some of the common conditions that Lidocaine Hydrochloride 2 mg/mL Injectable Solution is used to remedy?
"Lidocaine Hydrochloride 2 mg/mL Injectable Solution is most often used to lower intraocular pressure (IOP) but it also has other potential benefits, such as reducing nasal irritation and increasing renal excretion of toxic substances."
Are people with the qualifying condition currently being accepted into this research program?
"That is correct, according to the information displayed on clinicaltrials.gov this particular trial is ongoing and looking for 58 subjects from 1 site."
Has the FDA given Lidocaine Hydrochloride 2 mg/mL Injectable Solution its seal of approval?
"Lidocaine Hydrochloride 2 mg/mL Injectable Solution is considered safe according to our team's 3-point scale. This substance has gone through Phase 3 trials, which implies that not only does some data support its efficacy, but also that there are multiple rounds of data affirming its safety."
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