Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19

September 17, 2021 updated by: Marwa Kamal, Fayoum University
The objective of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine is a debilitating disorder that affects 37 million people in the United States. Recently, three new injectables calcitonin gene-related peptide (CGRP) receptor antagonists-erenumab, fremanezumab, and galcanezumab-were FDA approved for prophylactic treatment of migraine in adults, that plays a key role in migraine pathophysiology. By blocking the receptor function of CGRP, these agents can reduce the total number of headache days per month and limit the need for using multiple medications. In clinical trials, these agents, which have no drug interactions and minimal adverse reactions, reduced headache days per month by as much as 50% in patients experiencing multiple migraine days each month. These new biologics, however, are more expensive for the patient compared with other prophylactic treatments

The rational of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt, 63111
        • Marwa Kamal Ahmed Tolba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Migraine prevention is an area of a large unmet medical need, with existing prophylactic therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Egyptian adults with chronic migraine (CM).

The study consists of a screening period (up to 24 weeks, including at baseline period), a 12-week period and a 24-week period ,.

Description

Inclusion Criteria:

  • -Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All

  • History of at least 5 attacks of migraine

    -≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period

  • chronic migraineurs with failure to more than 2 preventive treatments
  • chronic migraineurs without any preventive treatments
  • Naive to anti CGRP monclonal antibodies

Exclusion Criteria:

  • 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;

  • History of cluster or hemiplegic headache
  • Evidence of seizure or major psychiatric disorder Cardiac or active hepatic disease
  • pregnant, actively trying to become pregnant, or breast-feeding;
  • episodic migraineurs,
  • Other headache types
  • allergy to latex;
  • 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;
  • a psychiatric condition, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean number of migraine days
Time Frame: 6 months
The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month.
6 months
changes on migraine severity during COVID-19 infection
Time Frame: during the 6 months
measuring the severity of migraine attacks on a numerical scale
during the 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in migraine days
Time Frame: during the 6 months
Secondary end points were a 50% or greater reduction in mean migraine days per month
during the 6 months
rate of using migraine medications
Time Frame: during the 6 months
change in the number of days of use of acute migraine-specific medication
during the 6 months
assessment of migraine effect on physical activity
Time Frame: during the 6 months
change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher score
during the 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erenumab in migraine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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