Ensayos clínicos

Inclusion Criteria:

• Age 18 years and older (no upper age limit defined).
• History of chronic migraine as defined by the International Headache Society’s International Classification of Headache Disorders (3rd edition)8.
• Receiving onabotulinum toxin A injections following a PREEMPT protocol for treatment of chronic migraine for ≥ 1 year.
• Response to therapy with onabotulinum toxin A injections of ≥ 50% improvement in the frequency of headache days when compared to baseline.
• 4 to 14 average number of total headaches days per month during peak efficacy of onabotulinum toxin A injections.
• Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
• Patient agrees to maintain a daily electronic headache diary.
• Proficient in the use of electronic devices including Apple HomeKit and Apple Watch. Subjects owns an iPhone 6s or later with iOS 15 or later operating system installed on iPhone. Apple watch with watch OS6 will be provided by the study.
• Women of childbearing potential shall either be surgically sterile or must agree not to become pregnant for the duration of the study. Subjects of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study.
• If female, the subject may not be pregnant or breastfeeding. As per routine clinical care, patients who become pregnant while receiving onabotulinum toxin A injections will stop receiving the injections and detection of pregnancy will be guided by routine clinical practice.

Exclusion Criteria: 

• Chronic daily headache with no periods of headache freedom.
• ≥ 15 average number of headaches days per month during peak efficacy of onabotulinum toxin A injections.
• Medication overuse headache as defined by the International Headache Society’s International Classification of Headache Disorders (3rd edition)8.
• Daily opioid use for > 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) or other daily analgesic use for chronic pain disorders (e.g., NSAIDS or acetaminophen).
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/27/22. Questions regarding updates should be directed to the study team contact.