A Double Blind Randomized Controlled of Placebo and Nebul... | NCT00287781

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

NCT00287781

Sponsor

Kern Medical Center

Status

Completed

Last Update Posted

Jan 25, 2008Estimated

Enrollment

150

Phase

Not Applicable

Conditions

Migraine Headache

Interventions

Lidocaine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Feb 6, 2006

First Submission Date that Met QC Criteria

Feb 6, 2006

First Posted Date

Feb 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2008

Last Update Posted Date

Jan 25, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug

Measure	Description	Time Frame
Resolution of symptoms

Measure	Description	Time Frame
Improvement in 10 point pain score

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rick McPheeters, DO FAAEM	Kern Medical Center UCLA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kern Medical Center		Bakersfield	California	93305	United States

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders
D006261	Headache

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided