Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: onabotulinumtoxinA
Intervention description: BOTOX® (Formulation Number 9060X) contains 200 International Units (IU) of Clostridium botulinum Toxin Type A, reconstituted with 4 cc of normal saline providing 5 units per 0.1 cc. At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 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. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Migraine; onabotulinumtoxinA; Headache; Migraine; Neuronal regrowth; Botox

Summary:

      To obtain a patient specific understanding of response to treatment with onabotulinumtoxinA
      by collecting and correlating pre and post treatment subject specific history, clinical
      outcomes, and histological changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female 18 years or older.

          -  able to read, understand, and sign the informed consent.

          -  a negative urine pregnancy test at visit 1, if female, and of childbearing potential.
             Note: If female of childbearing potential, subject must agree to maintain true
             abstinence or use one of the listed methods of birth control for the duration of the
             study: hormonal contraceptive, intrauterine device (IUD), condoms, diaphragm, and/or
             have a male partner who has undergone a successful vasectomy. The use of barrier
             contraceptive (condom or diaphragm) should always be supplemented with the use of a
             spermicide.

        Note: To be considered not of childbearing potential, subject must be 6 weeks post-surgical
        bilateral oophorectomy, hysterectomy, bilateral tubal ligation, postmenopausal for at least
        one year.

          -  at least a one year history of migraine

          -  history of chronic migraine (with or without aura) according to the criteria of the
             International Classification of Headache Disorders (ICHD)-3 for at least 3 months
             prior to enrollment (Appendix I)

          -  able to differentiate migraine headache from any other headache they may experience
             (e.g., cluster headache)

          -  onset of migraine before age 50

          -  willing to provide responses to questionnaires and complete the online diary.

          -  if taking migraine preventive(s), be on a stable dose of the preventive medication for
             at least 30 days prior to screening

          -  concomitant medication dosages approved by the investigator

          -  email and internet access for completion of online diary

        Exclusion Criteria:

          -  previously used onabotulinumtoxinA as a migraine preventative or has used
             onabotulinumtoxinA for any other reason during the prior year

          -  female who is pregnant, planning to become pregnant during the study period, breast
             feeding, or is of childbearing potential and not practicing a reliable form of birth
             control

          -  headache disorders outside ICHD-3 defined chronic migraine that cannot be easily
             distinguished from CM (Appendix I)

          -  evidence of underlying pathology contributing to their headaches

          -  any medical condition that may increase their risk with exposure to BTX including
             diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or
             any other significant disease that might interfere with neuromuscular function

          -  profound atrophy or weakness of muscles in the target areas of injection

          -  skin conditions or infections at any of the injection sites

          -  allergy or sensitivities to any component of the test medication

          -  in the opinion of the investigator, has an active major psychiatric disorder including
             substance abuse and/or substance dependence within the last 12 months as determined by
             the investigator.

          -  Medication Overuse Headache as defined by ICHD-3 criteria for opioid or butalbital
             containing products (Appendix II)

          -  planning or requiring surgery during the study

          -  a history of poor compliance with medical treatment

          -  currently participating in an investigational drug study or has participated in an
             investigational drug study within the previous 30 days of the screening visit