Efficacy of Erenumab on Functional Impact of Migraine

NCT ID: NCT04465357

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2022-06-03

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Erenumab-Aooe 140 MG/ML [Aimovig]

Intervention Type: DRUG

140 mg/mL administered subcutaneously

Interventions

Erenumab-Aooe 140 MG/ML [Aimovig]

140 mg/mL administered subcutaneously

Intervention Type: DRUG

Other Intervention Names

Erenumab; Aimovig

Eligibility Criteria

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. willing to participate and sign informed consent;

2. ability to 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 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 4-20 migraine days and no more than 20 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 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. must have a score of ≥ 3 on the Migraine Functional Impact Questionnaire (MFIQ) overall impact on usual activities item at screening;

12. 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;

13. 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;

14. is willing to wear activity/sleep tracker throughout the duration of the trial;

15. has a smartphone and willing to install activity tracker app on phone.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

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, 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, or could increase the risk of adverse events;

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 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 preventative 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 previous 12 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 determine by the investigator;

15. 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;

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 12 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. active HIV or Hepatitis C infection;

18. allergy to latex;

19. score of > 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit;

20. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinvest Research, LLC

INDUSTRY

Sponsor Role: collaborator

Smith, Timothy R., M.D.

INDIV

Sponsor Role: collaborator

Merle Diamond

OTHER

Sponsor Role: lead

Responsible Party

Merle Diamond

President, Managing Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Merle Diamond, MD

Role: PRINCIPAL_INVESTIGATOR

Diamond Headache Clinic

Locations

Diamond Headache Clinic

Chicago, Illinois, United States

StudyMetrix

City of Saint Peters, Missouri, United States

Clinvest Research

Springfield, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

19-001AM

Identifier Type: -

Identifier Source: org_study_id