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Lidocaine for Migraine

Phase 3
Waitlist Available
Led By Katherine Chou, MD
Research Sponsored by New York City Health and Hospitals Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the nrs will be administered prior to study medication administration at baseline. as well as at 5 minutes, 10 minutes, and 20 minutes after study drug administration.
Awards & highlights

Study Summary

This trial will test whether intranasal lidocaine can help relieve pain for pediatric patients with migraines, comparing it to a placebo.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the nrs will be administered prior to study medication administration at baseline. as well as at 5 minutes, 10 minutes, and 20 minutes after study drug administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the nrs will be administered prior to study medication administration at baseline. as well as at 5 minutes, 10 minutes, and 20 minutes after study drug administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pain Score
Secondary outcome measures
The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine
The Number of Subjects Who Receive IV Pain Medications
The Number of Subjects with Improvement of Associated Symptoms
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LidocaineExperimental Treatment1 Intervention
Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved

Find a Location

Who is running the clinical trial?

New York City Health and Hospitals CorporationLead Sponsor
32 Previous Clinical Trials
8,423 Total Patients Enrolled
Katherine Chou, MDPrincipal InvestigatorNew York City Health and Hospitals Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to sign up for this experiment?

"The latest information on clinicaltrials.gov suggests that this study is still recruiting patients. The posting date was October 15th, 2018 and the last edit was December 31st, 2020. They are looking for a total of 50 participants at 1 location."

Answered by AI

Does this experiment only allow volunteers who are 25 or older?

"In order to participate in this clinical trial, applicants must be aged between 10 and 20 years old. There are 103 other studies for people who fall outside of that age range and are either under 18 or over 65."

Answered by AI

Are there any inclusion or exclusion criteria for this research?

"This study is in need of 50 individuals, aged 10-20, who have a history of migraines. Furthermore, it is essential that potential participants meet the following conditions: Patients must be unresponsive to oral painkillers as decided by their treating physician., The headache must rank moderate to severe on the NRS scale with a score of 6 or higher, Headache duration should fall between 2 and 72 hours, Headache should not originate from the occipital region (frontal, frontotemporal, or unilateral), pulsating or throbbing quality, aggravated by or causing avoidance of routine physical activity, nausea, vomiting, or both"

Answered by AI

Lidocaine is often prescribed to numb an area before a medical procedure. Is there another reason this medication might be taken?

"Lidocaine can be used to safely and effectively mitigate increased intra ocular pressure (iop), nasal irritation, and increased renal excretion of harmful substances."

Answered by AI

How many individuals are being given the opportunity to participate in this research?

"That is accurate, the online clinicaltrials.gov registry shows that this study is open and actively recruiting patients. The listing was created on 10/15/2018 and updated on 12/31/2020. They are looking to enroll 50 individuals at a single site."

Answered by AI

Can you give some examples of how Lidocaine has been studied in the past?

"Lidocaine is being researched in 235 active clinical trials, 60 of which are Phase 3. The majority of research sites for Lidocaine are located in Duarte, California; though, there are 1,475 total locations conducting trials for this medication."

Answered by AI

Has the FDA sanctioned lidocaine for medical use?

"Our analysts have given Lidocaine a score of 3 out of 3 for safety. This is because Phase 3 trials usually have some data to support efficacy as well as multiple rounds of data affirming safety."

Answered by AI
~8 spots leftby Apr 2025