Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]
Intervention description: 225 MG/1.5 ML Subcutaneous Solution
Intervention MeSH terms: Erenumab; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is being conducted to evaluate the efficacy and safety of AJOVY
      (fremanezumab-vfrm) on interictal migraine related burden in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. willing to participate and sign informed consent;

          2. ability to read and understand informed consent and study procedures, including able
             to use the electronic Daily Headache Diary;

          3. in good general health based on investigator's judgment;

          4. must be between 18 to 65 years of age, inclusive, at time of Visit 2;

          5. have migraine with and/or without aura meeting the diagnostic criteria listed in the
             International Classification of Headache Disorders 3rd edition (ICHD-III; Appendix 5);

          6. verification of headache frequency through prospectively collected baseline
             information during the 28-day screening/baseline phase reporting 4-22 migraine days
             and no more than 22 total headache days;

          7. onset of migraine before age 50;

          8. able to differentiate migraine from other primary headache types allowed in the study
             (e.g., tension-type headache);

          9. stable history of migraine at least 3 months prior to screening with at least some
             discreet headache free periods;

         10. not currently taking a migraine preventive OR has been taking a stable dose of a
             preventive for at least 90 days prior to screening and agrees to not start, stop, or
             change medication and/or dosage during the study period;

             * * participants on migraine preventive should have stable headache pattern

         11. women may be included only if they have a negative pregnancy test at screening and
             baseline, are sterile, or postmenopausal. Women of childbearing potential (WOCBP)
             engaging in potentially procreative intercourse must use highly effective birth
             control methods for the duration of the study (i.e., starting at screening).
             Definitions of WOCBP, sterile and postmenopausal women, male contraception, and highly
             effective and acceptable birth control methods are to be determined based on
             investigator's judgment;

         12. demonstrated compliance with the electronic Daily Headache Diary during the 28-day
             screening/baseline phase as defined by entry of headache data on a minimum of 23 days;

         13. is willing to wear activity/sleep tracker throughout the duration of the trial;

         14. has a smartphone and willing to install activity tracker app on phone.

        Exclusion Criteria:

          1. unable to understand the study requirements, the informed consent, or complete
             headache records as required per protocol;

          2. pregnant, actively trying to become pregnant, or breast-feeding;

          3. history of substance abuse and/or dependence that would interfere study conduction, in
             the opinion of the Investigator;

          4. history of impaired renal function that, in the investigator's opinion,
             contraindicates participation in this study;

          5. suffers from a serious illness, or an unstable medical condition, one that could
             require hospitalization, increase the risk of adverse events, or compromise data
             integrity (ie, likely require changes in con meds or lead to other medical
             investigations or treatments during the study).

          6. a psychiatric condition, in the opinion of the investigator, that may affect the
             interpretation of efficacy and safety data or contraindicates the participant's
             participation in the study;

          7. received nerve blocks or trigger point injections in the previous 8 weeks or plans to
             receive them during the study;

          8. prior exposure in the last 6 months, or 5 half-lives, to biologics or drugs
             specifically targeting the calcitonin gene-related peptide (CGRP) pathway;

          9. has failed more than 3 classes of medications for the prevention of migraine or >6
             migraine preventive medications of any type due to lack of efficacy;

         10. received any investigational agents within 30 days prior to Visit 1 (6 months for any
             investigational biological products unless previous study blind has been broken and
             subject was known to have received placebo);

         11. plans to participate in another clinical study at any time during this study;

         12. history of medication overuse of opioids or butalbital, as defined by opioid or
             butalbital use ≥10 days/month in each of the previous 3 months or during run-in
             period; Medication Overuse Headache (MOH) with other medication types will be allowed
             but must be documented;

         13. unstable medication use for migraine prevention (changes in the last 3 months);

         14. clinically relevant lab results at screening as determined by the investigator;

         15. clinically relevant or significant ECG abnormalities as determined by the
             investigator, including ECG with QT interval corrected for heart rate (QTc) using
             Fridericia's correction formula (QTcF) > 500 msec;

         16. history of any of the following cardiovascular conditions:

               1. Moderate to severe congestive heart failure (New York Heart Association class III
                  or IV);

               2. Recent (within past 6 months) cerebrovascular accident, myocardial infarction,
                  coronary stenting;

               3. Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160
                  mmHg or diastolic blood pressure > 100 mmHg.

         17. Subjects known to have active HIV or untreated Hepatitis C infection;

         18. score of > 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit;

         19. have any other condition, that in the judgment of the investigator, would make the
             participant unsuitable for inclusion, or would interfere with the participant
             participating in or completing the study.