A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Cady, Roger, M.D.
ClinicalTrials.gov Identifier:
NCT01700387
First received: October 1, 2012
Last updated: October 7, 2014
Last verified: October 2014
Results First Received: October 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Migraine
Intervention: Drug: onabotulinumtoxinA

  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

Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:

Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.

onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.

Group B

Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:

Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid

onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.


Participant Flow:   Overall Study
    Group A     Group B  
STARTED     10     10  
COMPLETED     6     6  
NOT COMPLETED     4     4  
Withdrawal by Subject                 1                 2  
Adverse Event                 1                 1  
Lost to Follow-up                 2                 1  



  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.
Only those subjects which randomized were included in the baseline analysis.

Reporting Groups
  Description
Group A

Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:

Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.

onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.

Group B

Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:

Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid

onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.

Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation
  40.84  ± 15.98     39.51  ± 6.99     40.18  ± 12.02  
Gender  
[units: participants]
     
Female     9     10     19  
Male     1     0     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     10     9     19  
Unknown or Not Reported     0     1     1  



  Outcome Measures
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1.  Primary:   Subject Attrition Post Randomization   [ Time Frame: Collected on Visit 2 (Day 29) through Visit 6 (Day 365) ]

2.  Primary:   Subject Global Impression of Change (SGIC)   [ Time Frame: Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365) ]

3.  Primary:   Physician Global Impression of Change (PGIC)   [ Time Frame: Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365) ]

4.  Primary:   Subject's Mental Efficiency Workload Test (MEWT) Overall Performance Index (PI) Score at Visits 2-6 to Measure Cognitive Efficiency   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Primary:   Subject's Controlled Oral Word Association Test (COWAT) Scores at Visits 2-6 to Measure Cognitive Efficiency   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Number of Headache Days Reported in 30-day Baseline Period vs. Treatment Period Months 1-12   [ Time Frame: 13 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Subject's Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   MEWT Score for Simple Reaction Time Sub-test at Visits 2-6 to Measure Mental Efficiency   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   MEWT Score for Running Memory Continuous Performance Task Sub-test at Visits 2-6 to Measure Mental Efficiency   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   MEWT Scores for Matching to Sample Sub-test at Visit 2-6 to Measure Mental Efficiency   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   MEWT Scores for Mathematical Processing Sub-test at Visits 2-6 to Measure Mental Efficiency   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Subject Estimation of Compliance With Daily Topiramate   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Pharmacoeconomic Estimates on Number of Patients Needed to Treat (Randomize) to Have One Successful Patient at 3, 6, 9, and 12 Months.   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 13 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting 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:  
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: Dr. Roger Cady
Organization: Clinvest/A Division of Banyan Group Inc.
phone: 417-883-7889
e-mail: rcady@banyangroupinc.com


Publications of Results:

Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01700387     History of Changes
Other Study ID Numbers: 12-001AL, 71403
Study First Received: October 1, 2012
Results First Received: October 7, 2014
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration