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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287781

Enrollment

150

Registered

2006-02-07

Start date

2002-01-31

Completion date

2006-04-30

Last updated

2008-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Headache

Keywords

Migraine, Lidocaine, Headache

Brief 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.

Interventions

DRUGLidocaine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Resolution of symptoms	—

Secondary

Measure	Time frame
Improvement in 10 point pain score	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026