Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• 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

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