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

This study has been completed.

Sponsor:

Information provided by:

Kern Medical Center

ClinicalTrials.gov Identifier:

NCT00287781

First received: February 6, 2006

Last updated: January 23, 2008

Last verified: January 2008

History of Changes

Purpose

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	Intervention
Migraine Headache	Drug: Lidocaine


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Kern Medical Center:

Primary Outcome Measures:

Resolution of symptoms

Secondary Outcome Measures:

Improvement in 10 point pain score


Estimated Enrollment:	150
Study Start Date:	January 2002
Estimated Study Completion Date:	April 2006

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287781

Locations


United States, California
Kern Medical Center
Bakersfield, California, United States, 93305

Sponsors and Collaborators

Kern Medical Center

Investigators


Principal Investigator:	Rick McPheeters, DO FAAEM	Kern Medical Center UCLA

More Information


ClinicalTrials.gov Identifier:	NCT00287781 History of Changes
Other Study ID Numbers:	#04028
Study First Received:	February 6, 2006
Last Updated:	January 23, 2008

Keywords provided by Kern Medical Center:


Migraine Lidocaine Headache

Additional relevant MeSH terms:


Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms 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

ClinicalTrials.gov processed this record on July 18, 2017

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