NCT00287781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

First QC Date

February 6, 2006

Last Update Submit

January 23, 2008

Conditions

Migraine Headache

Keywords

MigraineLidocaineHeadache

Outcome Measures

Primary Outcomes (1)

  • Resolution of symptoms

Secondary Outcomes (1)

  • Improvement in 10 point pain score

Interventions

LidocaineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets IHS criteria for migraine

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kern Medical Center

Bakersfield, California, 93305, United States

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rick McPheeters, DO FAAEM

    Kern Medical Center UCLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

January 1, 2002

Study Completion

April 1, 2006

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

US(1)