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Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

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ClinicalTrials.gov Identifier: NCT00660192
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Refractory Migraine
Interventions Drug: Botox
Other: Placebo
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Botox
Hide Arm/Group Description Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck. Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
Period Title: Overall Study
Started 12 13
Completed 10 10
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             3
Arm/Group Title Placebo Botox Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
59
(18 to 80)
61
(18 to 80)
60
(18 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
6
  50.0%
6
  46.2%
12
  48.0%
Male
6
  50.0%
7
  53.8%
13
  52.0%
Pain   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 13 participants 25 participants
8.1
(0 to 10)
8.3
(0 to 10)
8.24
(0 to 10)
[1]
Measure Description: Pain score on the Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.
1.Primary Outcome
Title Mean Number of Days of Decrease in Pain Level Using VAS
Hide Description Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botullinum Toxin
Hide Arm/Group Description:
Inactive Saline
Subjects injected with 100-200 units of botox depending on body and neck size
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: days
1.20  (5.63) 8.67  (8.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botullinum Toxin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0347
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Satisfied With Treatment
Hide Description

Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:

No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved

This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botullinum Toxin
Hide Arm/Group Description:
Inactive Saline
Subjects injected with 100-200 units of botox depending on body and neck size
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
9 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botullinum Toxin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0300
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Botox
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Saline Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Saline Botox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Botox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/13 (7.69%)    
Infections and infestations     
Cold symptoms  [1]  0/12 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Pain at injection site   0/12 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
Patient experienced colds symptoms 3-4 days after injection
Small study- results could have been different if numbers were larger Technique of injection different from PREEMPT study. Larger doses were injected into temporal and posterior neck muscles. No trapezius injection.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Baman,Jabbari M.D. Porfessor of Neurology
Organization: Yale School of Medicine
Phone: 203-737-2464
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00660192     History of Changes
Other Study ID Numbers: 0709003056
First Submitted: April 10, 2008
First Posted: April 17, 2008
Results First Submitted: August 18, 2014
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016