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NCT00287781 Clinical Trial

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

Migraine Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00287781
Other study ID # #04028
Secondary ID
Status Completed
Phase N/A
First received February 6, 2006
Last updated January 23, 2008
Start date January 2002
Est. completion date April 2006

Study information
Verified date January 2008
Source Kern Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine

Locations
Country Name City State
United States Kern Medical Center Bakersfield California

Sponsors (1)
Lead Sponsor Collaborator
Kern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resolution of symptoms
Secondary Improvement in 10 point pain score
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