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

NCT ID: NCT00287781

Last Updated: 2008-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lidocaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kern Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Rick McPheeters, DO FAAEM

Role: PRINCIPAL_INVESTIGATOR

Kern Medical Center UCLA

Locations

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Kern Medical Center

Bakersfield, California, United States

Site Status

Countries

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United States

Other Identifiers

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#04028

Identifier Type: -

Identifier Source: org_study_id

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