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MigrainePhase 4NCT04461795

Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden

A Phase 4 study testing Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY] in people with Migraine, run by David True at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
1 Dec 2020to 10 Jan 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • willing to participate and sign informed consent;
  • ability to read and understand informed consent and study procedures, including able to use the electronic Daily Headache Diary;
  • in good general health based on investigator's judgment;
  • must be between 18 to 65 years of age, inclusive, at time of Visit 2;
  • 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);
  • 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;
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  • onset of migraine before age 50;
  • able to differentiate migraine from other primary headache types allowed in the study (e.g., tension-type headache);
  • stable history of migraine at least 3 months prior to screening with at least some discreet headache free periods;
  • 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
  • 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;
  • 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;
  • is willing to wear activity/sleep tracker throughout the duration of the trial;
  • has a smartphone and willing to install activity tracker app on phone.

Who cannot join

  • unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
  • pregnant, actively trying to become pregnant, or breast-feeding;
  • history of substance abuse and/or dependence that would interfere study conduction, in the opinion of the Investigator;
  • history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study;
  • 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).
  • 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;
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  • received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
  • prior exposure in the last 6 months, or 5 half-lives, to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
  • 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;
  • 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);
  • plans to participate in another clinical study at any time during this study;
  • 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;
  • unstable medication use for migraine prevention (changes in the last 3 months);
  • clinically relevant lab results at screening as determined by the investigator;
  • 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;
  • history of any of the following cardiovascular conditions:
  • Moderate to severe congestive heart failure (New York Heart Association class III or IV);
  • Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting;
  • Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
  • Subjects known to have active HIV or untreated Hepatitis C infection;
  • score of > 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit;
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • StudyMetrix

    City of Saint Peters, Missouri, 63303

  • Clinvest Research, LLC

    Springfield, Missouri, 65810

Other trials in United States

About this study

Official title: A Multicenter, Open Label Study Assessing the Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden

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

Read the 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.

Conditions
Migraine
Being tested
Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]Drug

    Also called fremanezumab-vfrm

    225 MG/1.5 ML Subcutaneous Solution

Study groups in NCT04461795
Study groupRoleWhat they receive
AJOVY (fremanezumab-vfrm)ExperimentalParticipants received 225 mg/1.5 mL solution via single-dose prefilled syringe administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for 12 weeks.
Receives: Drug: Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline to Weeks 4, 8, and 12

Secondary outcomes (6)

  1. 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)

    Measured: Baseline to Weeks 4, 8, and 12

  2. 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)

    Measured: Baseline to Weeks 4, 8, and 12

  3. 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)

    Measured: Baseline to Weeks 4, 8, and 12

  4. 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)

    Measured: Baseline to Weeks 4, 8, and 12

  5. 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)

    Measured: Baseline to Weeks 4, 8, and 12

  6. 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)

    Measured: Baseline to Weeks 4, 8, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start1 Dec 2020
  3. Primary completion10 Jan 2022
  4. Study completion10 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461795
Sponsor's protocol ID
19-001TE
Status last verified
Apr 2022
First submitted
2 Jul 2020
Last updated
13 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY] in people with Migraine, run by David True at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Migraine Interictal Burden Scale (MIBS-4) Scores From Baseline to Weeks 4, 8, and 12. (time frame: Baseline to Weeks 4, 8, and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04461795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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