MigrainePhase 4NCT04465357

Efficacy of Erenumab on Functional Impact of Migraine

A Phase 4 study testing Erenumab-Aooe 140 MG/ML [Aimovig] in people with Migraine, run by Merle Diamond at 3 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

The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine 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?: Erenumab-Aooe 140 MG/ML [Aimovig]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 3 sitesUnited States
Study dates: 22 Oct 2020to 3 Jun 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

Participants are eligible to be included in the study only if all of the following criteria apply:
willing to participate and sign informed consent;
ability to 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 or without aura meeting the diagnostic criteria listed in the International Classification of Headache Disorders 3rd edition (ICHD-III; Appendix 5);

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verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase reporting 4-20 migraine days and no more than 20 total headache days;
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 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
must have a score of ≥ 3 on the Migraine Functional Impact Questionnaire (MFIQ) overall impact on usual activities item at screening;
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) whose male partners are potentially fertile (i.e., no vasectomy) 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

Participants are excluded from the study if any of the following criteria apply:
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, 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, or could increase the risk of adverse events;

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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;
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 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 preventative 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 previous 12 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 determine by the investigator;
clinically relevant or significant ECG abnormalities as determine 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 12 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.
active HIV or Hepatitis C infection;
allergy to latex;
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

3 sites in 1 country.

United States3 sites

Diamond Headache Clinic
Chicago, Illinois, 60642
StudyMetrix
City of Saint Peters, Missouri, 63303
Clinvest Research
Springfield, Missouri, 65810

Other trials in United States

About this study

Official title: A Multicenter, Open Label Study Assessing the Efficacy of Erenumab on Functional Impact of Migraine

The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine 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 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 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: Erenumab-Aooe 140 MG/ML [Aimovig]
Medical subject headings: Migraine Disorders

What participants receive

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

Erenumab-Aooe 140 MG/ML [Aimovig]Drug
Also called Erenumab, Aimovig
140 mg/mL administered subcutaneously

Study groups in NCT04465357
Study group	Role	What they receive
Erenumab-Aooe 140 MG/ML [Aimovig]	Experimental	Participants received 140 mg/mL administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for three months (12 weeks). Receives: Drug: Erenumab-Aooe 140 MG/ML [Aimovig]

What is being measured

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

Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Month 3

Secondary outcomes (18)

Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Physical Function" Domain Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Physical Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Usual Activities" Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Usual Activities. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Emotional Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Social Function" Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Social Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Physical Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Physical Function The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Usual Activities" Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Usual Activities. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Emotional Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Social Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Social Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Measured: Baseline and Treatment Months 1, 2, and 3
Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3.
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). Higher scores indicate worse interictal burden.
Measured: Baseline and Treatment Months 1, 2, and 3
Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3.
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]).
Measured: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
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. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Measured: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
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. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Measured: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
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. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Measured: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
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. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Measured: Baseline and Treatment Months 1, 2, and 3
Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3.
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 transformed t-scores ranging from 32 to 84.20, with higher scores indicating worse sleep habits.
Measured: Baseline and Treatment Months 1, 2, and 3
General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3.
The General Self-Efficacy Severity Scale (GSESS) is a 4 item, self-administered questionnaire where the participant is asked to rate their confidence in managing situations, problems, and events. Final scores range from 18.60 to 64.70 and are represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate the participant has more self-efficacy managing difficult situations.
Measured: Baseline and Treatment Months 1, 2, and 3
Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3
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.
Measured: Baseline and Treatment Months 1, 2, and 3

Timeline

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

22 Oct 20203 Jun 2022

First posted10 Jul 2020
Study start22 Oct 2020
Primary completion3 Jun 2022
Study completion3 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04465357
Sponsor's protocol ID: 19-001AM
Status last verified: Sep 2022
First submitted: 7 Jul 2020
Last updated: 5 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open Label Study Assessing the Efficacy of Erenumab on Functional Impact of Migraine
ClinicalTrials.gov ID: NCT04465357
Acronym / sponsor ID: 19-001AM
Conditions: Migraine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Merle DiamondUniversity, hospital or other
Collaborators: Clinvest Research, LLC, Smith, Timothy R., M.D.
Study start: 22 Oct 2020 (actual)
Primary completion: 3 Jun 2022 (actual)
Study completion: 3 Jun 2022 (actual)
First posted: 10 Jul 2020 (actual)
Results: Posted 5 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erenumab-Aooe 140 MG/ML [Aimovig]	Experimental	Drug: Erenumab-Aooe 140 MG/ML [Aimovig]Participants received 140 mg/mL administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for three months (12 weeks).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Participants are eligible to be included in the study only if all of the following criteria apply:
willing to participate and sign informed consent;
ability to 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;

Key exclusion criteria (24 listed)

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, 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, or could increase the risk of adverse events;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erenumab-Aooe 140 MG/ML [Aimovig]Also: Erenumab, Aimovig140 mg/mL administered subcutaneously	Drug	Erenumab-Aooe 140 MG/ML [Aimovig]

Primary outcome

Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3).
Time frame: Baseline and Treatment Month 3
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant.

18 secondary outcomes

Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Physical Function" Domain Scores at Baseline and at the End of Treatment (Treatment Month 3).
Time frame: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Usual Activities" Scores at Baseline and at the End of Treatment (Treatment Month 3).
Time frame: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at the End of Treatment (Treatment Month 3).
Time frame: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Social Function" Scores at Baseline and at the End of Treatment (Treatment Month 3).
Time frame: Baseline and Treatment Month 3
Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Physical Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Usual Activities" Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Social Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3.
Time frame: Baseline and Treatment Months 1, 2, and 3
Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3
Time frame: Baseline and Treatment Months 1, 2, and 3

Results and safety

Results posted to the registry on 5 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erenumab-Aooe 140 MG/ML [Aimovig]	55	42

Primary outcome: Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3).

Time frame: Baseline and Treatment Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Erenumab-Aooe 140 MG/ML [Aimovig] n = 55
Baseline	43.64 (23.18)
Treatment Month 3	21.82 (20.44)

Population analysed: Full analysis population

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks (from Visit 2 [enrollment visit] to Visit 5 [end of study]). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erenumab-Aooe 140 MG/ML [Aimovig]	0 of 55 (0%)	3 of 55 (5.5%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Merle Diamond, MD principal investigator

Diamond Headache Clinic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erenumab-Aooe 140 MG/ML [Aimovig] in people with Migraine, run by Merle Diamond at 3 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 17 inclusion and 24 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 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 5 Oct 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?

Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3). (time frame: Baseline and Treatment Month 3). 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 NCT04465357.

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 5 Oct 2022.