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

This study has been completed.
Information provided by:
Kern Medical Center
ClinicalTrials.gov Identifier:
First received: February 6, 2006
Last updated: January 23, 2008
Last verified: January 2008
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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

United States, California
Kern Medical Center
Bakersfield, California, United States, 93305
Sponsors and Collaborators
Kern Medical Center
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
Health Authority: United States: Institutional Review Board

Keywords provided by Kern Medical Center:

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Anti-Arrhythmia Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 26, 2016