Clinical trial NCT04461795: Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden
Official title: A Multicenter, Open Label Study Assessing the Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Clinvest Research, LLC
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

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.

Primary outcomes:
measure: Change in Migraine Interictal Burden Scale (MIBS-4) Scores From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
Secondary outcomes:
measure: Change in Number of Monthly Migraine Days From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in General Self-Efficacy - Short Form (GSE-SF) Scores From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) Global Pain Intensity Scores From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in Work Productivity and Activity Impairment - Migraine (WPAI-M) Activity Impairment Scores From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in Brief Measure of Worry Severity (BMWS) Scores From Baseline to Weeks 4, 8, and 12.
timeFrame: Baseline to Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Saint Peters
country: United States
facility: StudyMetrix
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
Study officials:
affiliation: Clinvest Research
name: David True
role: PRINCIPAL_INVESTIGATOR
References: