Skip to main content
OpenTrials
Completed

NCT Number: NCT05052008

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marwa Kamal Ahmed Tolba

Al Fayyum, 63111, Egypt

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erenumab

Drug

Erenumab is monoclonal antibody used for management of migraine

Primary outcomes

  1. 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.

  2. changes on migraine severity during COVID-19 infection

    Time frame: during the 6 months

    measuring the severity of migraine attacks on a numerical scale

Secondary outcomes

  1. 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

  2. rate of using migraine medications

    Time frame: during the 6 months

    change in the number of days of use of acute migraine-specific medication

  3. 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.