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A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287781
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
Kern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Lidocaine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
Study Start Date : January 2002
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Resolution of symptoms

Secondary Outcome Measures :
  1. Improvement in 10 point pain score

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287781


Locations
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United States, California
Kern Medical Center
Bakersfield, California, United States, 93305
Sponsors and Collaborators
Kern Medical Center
Investigators
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Principal Investigator: Rick McPheeters, DO FAAEM Kern Medical Center UCLA
More Information
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ClinicalTrials.gov Identifier: NCT00287781    
Other Study ID Numbers: #04028
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008
Keywords provided by Kern Medical Center:
Migraine
Lidocaine
Headache
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action