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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:
ClinicalTrials.gov Identifier:
NCT01700387
First Posted: October 4, 2012
Last Update Posted: November 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Cady, Roger, M.D.
Results First Submitted: October 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Migraine
Interventions: Drug: onabotulinumtoxinA
Drug: Topiramate
Drug: 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
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
OnabotulinumtoxinA + Topiramate

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 qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg 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.

OnabotulinumtoxinA + Placebo

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 qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs 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
    OnabotulinumtoxinA + Topiramate   OnabotulinumtoxinA + Placebo
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
OnabotulinumtoxinA + Topiramate

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 qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg 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.

OnabotulinumtoxinA + Placebo

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 qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs 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
   OnabotulinumtoxinA + Topiramate   OnabotulinumtoxinA + Placebo   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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.  

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.  

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.  

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.  

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.  

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.  

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.  

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.  

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

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.  

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.  

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.  


  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
No text entered.


  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 ( Other Grant/Funding Number: Allergan )
First Submitted: October 1, 2012
First Posted: October 4, 2012
Results First Submitted: October 7, 2014
Results First Posted: October 13, 2014
Last Update Posted: November 25, 2014