This study is being conducted to evaluate the efficacy and safety of AJOVY (fremanezumab-vfrm) on interictal migraine related burden in adults.
This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 22 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 40 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
225 MG/1.5 ML Subcutaneous Solution
StudyMetrix
City of Saint Peters, Missouri, United States
Clinvest Research, LLC
Springfield, Missouri, United States
Change in Migraine Interictal Burden Scale (MIBS-4) Scores From Baseline to Weeks 4, 8, and 12.
The Migraine Interictal Burden Scale (MIBS-4) is a 4-item, self-administered questionnaire which measures interictal migraine-related burden in 4 domains: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Possible scores range from 0 (No interictal burden) to 12 (Severe interictal burden). Change = (Applicable Treatment Month Score - Baseline Score)
Time frame: Baseline to Weeks 4, 8, and 12
Change in Number of Monthly Migraine Days From Baseline to Weeks 4, 8, and 12.
Comparison of the mean change from baseline in the frequency of migraine headache days per 28-day period ending with the cessation of treatment month 3. A migraine headache day will be defined as a calendar day (00:00 to 23:59) with 4 or more hours of migraine headache, fulfilling International Classification of Headache Disorders-3 criteria, and/or any headache of any duration with the use of migraine-specific acute medications(s) (i.e. ergot alkaloids, ergot combinations, opioids, triptans, combination analgesics \[simple analgesics combined with opioids or barbiturate with or without caffeine\]). Change = (Applicable Treatment Month Score - Baseline Score)
Time frame: Baseline to Weeks 4, 8, and 12
Change in Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores From Baseline to Weeks 4, 8, and 12.
The Neuro-QoL Sleep Disturbance Short Form (SDSF) is an 8-item, self-administered questionnaire which measures quality of sleep including difficulties and perception of sleep satisfaction. Possible scores range from 8 to 40, with higher scores indicating worse sleep habits. Change = (Applicable Treatment Month Score - Baseline Score)
Time frame: Baseline to Weeks 4, 8, and 12
Change in General Self-Efficacy - Short Form (GSE-SF) Scores From Baseline to Weeks 4, 8, and 12.
The General Self-Efficacy - Short Form (GSE-SF) is a 4 item, self-administered questionnaire where the participant is asked to rate their confidence in managing situations, problems, and events. Scores range from 4-20. Higher scores indicate the participant has more self-efficacy managing difficult situations. Change = (Applicable Treatment Month Score - Baseline Score)
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Time frame: Baseline to Weeks 4, 8, and 12
Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) Global Pain Intensity Scores From Baseline to Weeks 4, 8, and 12.
The Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) has 7 domains each with 4 questions, and then one global Pain Intensity item. The domains include: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. The global item domain is Pain Intensity. Each PROMIS domain can range from a score of 4-20, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). The outcome measure for this endpoint is the change in the global item (Pain Intensity) from baseline. The Global Pain Intensity item can range from 0-10, with higher scores indicating more severe pain intensity. Change = (Applicable Treatment Month Score - Baseline Score)
Time frame: Baseline to Weeks 4, 8, and 12
Change in Work Productivity and Activity Impairment - Migraine (WPAI-M) Activity Impairment Scores From Baseline to Weeks 4, 8, and 12.
The Work Productivity and Activity Impairment - Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Scores are based on a percentage, so the range of scores is 0-100%, with higher scores indicating greater impairment and less productivity. Change = (Applicable Treatment Month Score - Baseline Score)
Time frame: Baseline to Weeks 4, 8, and 12
Change in Brief Measure of Worry Severity (BMWS) Scores From Baseline to Weeks 4, 8, and 12.
The Brief Measure of Worry Severity (BMWS) is a 8-item, self-administered questionnaire that measures various components of dysfunctional worry. Score range from 0-24 with higher scores indicating more worry within the participant. Change = (Applicable Treatment Month Score - Baseline Score)
Time frame: Baseline to Weeks 4, 8, and 12