Calcitonin Gene-related Peptide Levels in Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: OnabotulinumtoxinA; Saline
Intervention description: Minimum dose of 155 U OnabotulinumtoxinA Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven specific head/neck muscle areas. Subjects will continue to monitor headache symptoms with a headache diary and collect saliva samples as instructed.
At investigator's discretion, additional 40 U OnabotulinumtoxinA Purified Neurotoxin Complex may be administered unilaterally or bilaterally, using follow-the-pain paradigm.; 155 U Saline administered at 31 fixed-site, fixed-dose injections across seven specific head/neck muscle areas. Subjects will continue to monitor headache using a headache diary and collect saliva samples as instructed.
At investigator's discretion, additional Saline may be administered unilaterally or bilaterally, using follow-the-pain paradigm.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Botox; OnabotulinumtoxinA; Chronic Migraine; Calcitonin Gene-Related Peptide; Saliva

Summary:

      Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to
      evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP)
      levels in saliva following treatment with OnabotulinumtoxinA versus saline.

      Eligible patients will be randomized and receive injections of OnabotulinumtoxinA or Saline
      at Visit 1. Following 3 months plus a 1 month wash out, patients will receive cross-over
      injections at Visit 5.

      Patients will return for monthly visits and exit the study at Visit 8.

      Patients will collect saliva at monthly intervals and document in a daily headache diary
      throughout the study .
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be outpatient, male or female, of any race, between 18 and 65 years of age.

          -  if female of childbearing potential must have negative pregnancy test result at
             Screening Visit and practice 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; or,
        History of bilateral tubal ligation; or, 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 methods is less than 1% per year.

          -  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.

          -  must be able to understand the requirements of the study including maintaining a
             headache Diary, and signing informed consent.

          -  must be in good general health as determined by investigator.

          -  if taking migraine preventive, must be on a stable dose of preventive medication for
             at least 3 months prior to screening.

        Exclusion Criteria:

          -  if female, is pregnant, planning to become pregnant during the study period, is breast
             feeding, or is of childbearing potential and not practicing a reliable form of birth
             control.

          -  has headache disorders outside IHS-defined chronic migraine definition.

          -  has evidence of underlying pathology contributing to their headaches.

          -  has any pathology of the salivary glands such as sialadenitis (e.g. Sjogren's
             syndrome, viral or bacterial sialadenitis) or condition or symptom that would alter
             the content of saliva.

          -  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.

          -  has profound atrophy or weakness of muscles in the target areas of injection.

          -  has skin conditions or infections at any of the injection sites.

          -  has allergy or sensitivities to any component of the test medication.

          -  who in the opinion of the investigator, has active major psychiatric or depressive
             disorders including alcohol/drug abuse.

          -  meets International Headache Society criteria for Medication Overuse with opioid or
             butalbital containing products.

          -  is planning or requiring surgery during the study.

          -  has a history of poor compliance with medical treatment.

          -  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.