Back to resultsA Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
Primary Purpose
Migraine Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache focused on measuring Migraine, Lidocaine, Headache
Eligibility Criteria
Inclusion Criteria: Meets IHS criteria for migraine Exclusion Criteria: Pregnant Breast feeding Allergic to Lidocaine Worst or first Headache Abnormal neurological exam Substance abuse within 6 months Cardiac, liver or pulmonary disease Participation n another study within 30 days
Sites / Locations
- Kern Medical Center
Outcomes
Primary Outcome Measures
Resolution of symptoms
Secondary Outcome Measures
Improvement in 10 point pain score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00287781
Brief Title
A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
Official Title
A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kern Medical Center
4. Oversight
5. Study Description
Brief Summary
Migraine headaches have previously been shown to be responsive to intranasal lidocaine in a small study. Using a nebulizer to administer the drug would improve the feasibility of using the treatment. It would also spare the patient narcotics with their attendant side effects. Because of the potential for placebo effect a placebo control is necessary in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Migraine, Lidocaine, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
Resolution of symptoms
Secondary Outcome Measure Information:
Title
Improvement in 10 point pain score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets IHS criteria for migraine
Exclusion Criteria:
Pregnant
Breast feeding
Allergic to Lidocaine
Worst or first Headache
Abnormal neurological exam
Substance abuse within 6 months
Cardiac, liver or pulmonary disease
Participation n another study within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick McPheeters, DO FAAEM
Organizational Affiliation
Kern Medical Center UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kern Medical Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
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