Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine
Completed · Phase 4
Conditions studied: Chronic Migraine
In brief
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.
Key facts
- Study ID
- NCT02037425
- Run by
- Cady, Roger, M.D.
- People needed
- 44
- Starts
- 2014-04-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2016-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinvest/A Division of Banyan Group, Inc. — Springfield, Missouri, United States
Full record on ClinicalTrials.gov
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