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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate sustained tolerability, quality of life, and change in cognitive efficiency following treatment with OnabotulinumtoxinA and daily topiramate vs. OnabotulinumtoxinA and daily placebo (Group A vs. Group B).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cady, Roger, M.D.
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Topiramate

Criteria

Inclusion Criteria:

1. must be outpatient, male or female, of any race, between 18 and 65 years of age.

2. if female of child bearing potential must have a negative pregnancy test result at the Screening Visit and practice a reliable method of contraception.

A female is considered of childbearing potential unless she is post-menopausal for at least 12 months prior to administration of study drug, without a uterus and/or both ovaries or has been surgically sterilized for at least 6 months prior to study drug administration.

Reliable methods of contraception are:

Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product. Throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study. History of bilateral tubal ligation Sterilization of male partner; or, Implants of levonorgestrel; or, Injectable progestogen, or, Oral contraceptive (combination therapy with ethinyl estradiol plus a progestin) with a placebo week every 1-3 months; or, Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUD's meet this criterion) in use at least 30 days prior to study drug administration; or, Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, Any other barrier methods (only is used in combination with any of the above acceptable methods) in use at least 14 days prior to study drug administration; or, Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year.

3. must have history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society (IHS) for at least 3 months prior to enrollment.

4. must be able to understand the requirements of the study including maintaining a headache Diary, and signing informed consent.

5. must be in good general health as determined by investigator.

6. if taking migraine preventive, must be on a stable dose of preventive medication for at least 6 weeks prior to screening.

7. must have daily access to internet for completion of online daily headache diary.

Exclusion Criteria:

1. if female, is pregnant, planning to become pregnant during the study period, are breast feeding, or are of childbearing potential and not practicing a reliable form of birth control.

2. has headache disorders outside IHS-defined chronic migraine definition.

3. has evidence of underlying pathology contributing to their headaches.

4. has any medical condition that may increase their risk with exposure to OnabotulinumtoxinA including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

5. has profound atrophy or weakness of muscles in the target areas of injection.

6. has skin conditions or infections at any injection site.

7. has allergy or sensitivities to any component of the test medication.

8. has previously received onabotulinumtoxinA for migraine prevention.

9. has previously received topiramate.

10. who in the opinion of the investigator, has active major psychiatric or depressive disorders including alcohol/drug abuse.

11. meets International Headache Society criteria for Medication Overuse Headache with opioid or butalbital containing products.

12. who in the opinion of the investigator, is taking opioid or butalbital containing products more than once a week that could be contributing to a pattern of increased headaches or cognitive decline.

13. is planning or requiring surgery during the study.

14. has a history of poor compliance with medical treatment.

15. is currently participating in an investigational drug study or has participated in an investigational drug study within the previous 30 days of the screening visit.