Efficacy of Erenumab on Functional Impact of Migraine

NCT04465357 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-001AM
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  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).

  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).

  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).

  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.

  Baseline and Treatment Months 1, 2, and 3

Study Arms (1)

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).

Drug: Erenumab-Aooe 140 MG/ML [Aimovig]

Interventions

Erenumab-Aooe 140 MG/ML [Aimovig] DRUG

140 mg/mL administered subcutaneously

Also known as: Erenumab, Aimovig

Erenumab-Aooe 140 MG/ML [Aimovig]

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Merle Diamond: lead
• Clinvest Research, LLC: collaborator
• Smith, Timothy R., M.D.: collaborator

Study Sites (3)

Diamond Headache Clinic

Chicago, Illinois, 60642, United States

Location

StudyMetrix

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research

Springfield, Missouri, 65810, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Jim Sly
• Organization: Clinvest Research

jsly@clinvest.com

4178413673

Study Officials

• Merle Diamond, MD

  Diamond Headache Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President, Managing Director

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: October 22, 2020
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Locations

US (3)