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

This study has been terminated.
(Study terminated due to inadequate recruitment)
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329732
First received: May 24, 2006
Last updated: July 21, 2011
Last verified: July 2011
Results First Received: May 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine
Interventions: Drug: 0.5% bupivicaine and 2% lidocaine
Drug: Saline placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lidocaine/Bupivicaine No text entered.
Saline (Placebo) No text entered.

Participant Flow:   Overall Study
    Lidocaine/Bupivicaine     Saline (Placebo)  
STARTED     2     0  
COMPLETED     2     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lidocaine/Bupivicaine No text entered.
Saline (Placebo) No text entered.
Total Total of all reporting groups

Baseline Measures
    Lidocaine/Bupivicaine     Saline (Placebo)     Total  
Number of Participants  
[units: participants]
  2     0     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     0     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     0     2  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     2     0     2  



  Outcome Measures

1.  Primary:   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.   [ Time Frame: 30 minutes ]

2.  Secondary:   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;   [ Time Frame: 30 minutes ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   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.   [ Time Frame: 30 minutes ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   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;   [ Time Frame: 30 minutes ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kathleen Bradley
Organization: Thomas Jefferson University
phone: 215-955-2025
e-mail: Kathleen.Bradley@jefferson.edu


No publications provided


Responsible Party: Bruce Smith, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00329732     History of Changes
Other Study ID Numbers: GON-DBPC/WBY
Study First Received: May 24, 2006
Results First Received: May 24, 2011
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board