Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks

NCT00329732 | Terminated Results

• 1 other identifier: GON-DBPC/WBY
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician. 40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.

  30 minutes

Secondary Outcomes (3)

• Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;

  30 minutes

• Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.

  30 minutes

• Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;

  30 minutes

Study Arms (2)

Lidocaine/Bupivicaine

ACTIVE COMPARATOR

Drug: 0.5% bupivicaine and 2% lidocaine

saline

PLACEBO COMPARATOR

matching volume of saline injected

Drug: Saline placebo

Interventions

0.5% bupivicaine and 2% lidocaine DRUG

The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache

Lidocaine/Bupivicaine

Saline placebo DRUG

matching volume of saline (placebo)

saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine
• Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.
• Pain must be reported as at least moderate pain level at time of injections

You may not qualify if:

• A subject is ineligible to participate in this study if he/she satisfies any of the following criteria:
• Subjects who have received greater occipital nerve blocks in the past
• Subjects who in their own or the investigator's opinion are unable to describe their symptoms
• Subjects who are pregnant or lactating

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center/Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Kathleen Bradley
• Organization: Thomas Jefferson University

Kathleen.Bradley@jefferson.edu

215-955-2025

Study Officials

• William B Young, M.D.

  Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 6, 2015
• Results First Posted: June 27, 2011

Record last verified: 2015-04

Locations

US (1)