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

NCT04461795 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-001TE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (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)

  Baseline to Weeks 4, 8, and 12

Secondary Outcomes (6)

• Change in Number of Monthly Migraine Days From Baseline to Weeks 4, 8, and 12.

  Baseline to Weeks 4, 8, and 12

• Change in Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores From Baseline to Weeks 4, 8, and 12.

  Baseline to Weeks 4, 8, and 12

• Change in General Self-Efficacy - Short Form (GSE-SF) Scores From Baseline to Weeks 4, 8, and 12.

  Baseline to Weeks 4, 8, and 12

• Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) Global Pain Intensity Scores From Baseline to Weeks 4, 8, and 12.

  Baseline to Weeks 4, 8, and 12

• Change in Work Productivity and Activity Impairment - Migraine (WPAI-M) Activity Impairment Scores From Baseline to Weeks 4, 8, and 12.

  Baseline to Weeks 4, 8, and 12

Study Arms (1)

AJOVY (fremanezumab-vfrm)

EXPERIMENTAL

Participants 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.

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

Interventions

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

225 MG/1.5 ML Subcutaneous Solution

Also known as: fremanezumab-vfrm

AJOVY (fremanezumab-vfrm)

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• David True: lead

Study Sites (2)

StudyMetrix

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research, LLC

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

417-841-3673

Study Officials

• David True

  Clinvest Research

  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: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: December 1, 2020
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-04

Locations

US (2)