Calcitonin Gene-related Peptide Levels in Chronic Migraine

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Cady, Roger, M.D.
ClinicalTrials.gov Identifier:
NCT01071096
First received: February 17, 2010
Last updated: February 6, 2013
Last verified: February 2013
Results First Received: January 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Migraine
Interventions: Drug: OnabotulinumtoxinA
Drug: Saline

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
Group B Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).

Participant Flow for 3 periods

Period 1:   First Intervention (90 Days)
    Group A     Group B  
STARTED     10     10  
COMPLETED     9     10  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  

Period 2:   Washout Period (30 Days)
    Group A     Group B  
STARTED     9     10  
COMPLETED     9     10  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (90 Days)
    Group A     Group B  
STARTED     9     10  
COMPLETED     9     10  
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.
No text entered.

Reporting Groups
  Description
Enrolled Participants Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).

Baseline Measures
    Enrolled Participants  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.45  ± 12.87  
Gender  
[units: participants]
 
Female     15  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.   [ Time Frame: Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7 ]

2.  Primary:   Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).   [ Time Frame: Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7 ]

3.  Secondary:   Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)   [ Time Frame: Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7 ]

4.  Secondary:   Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline   [ Time Frame: For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 ]

5.  Secondary:   Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders   [ Time Frame: For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy ]


  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
Due to identified lab errors related to processing of samples for CGRP and cytokine levels, samples are currently being re-processed. Results will be posted following re-analysis of all study data related to sample values.


  More Information
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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: Jeanne Tarrasch
Organization: Clinvest
phone: 417-841-3673
e-mail: jtarrasch@clinvest.com


Publications:

Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01071096     History of Changes
Other Study ID Numbers: 10-001AL
Study First Received: February 17, 2010
Results First Received: January 16, 2012
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board