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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
Endpoint Classification: Efficacy Study
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
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
Genders Eligible for Study:   Both
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
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

Additional Information:
Departmental Web page  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00287781     History of Changes
Other Study ID Numbers: #04028
Study First Received: February 6, 2006
Last Updated: January 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Kern Medical Center:
Migraine
Lidocaine
Headache

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Lidocaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013