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

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT05052008
Collaborator
(none)
90
Enrollment
1
Location
12.8
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
Aug 10, 2021
Actual Study Completion Date :
Sep 10, 2021

Outcome Measures

Primary Outcome Measures

  1. mean number of migraine days [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 [during the 6 months]

    measuring the severity of migraine attacks on a numerical scale

Secondary Outcome Measures

  1. reduction in migraine days [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marwa Kamal Ahmed Tolba Fayoum Egypt 63111

Sponsors and Collaborators

  • Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marwa Kamal, Principle investigator, Fayoum University
ClinicalTrials.gov Identifier:
NCT05052008
Other Study ID Numbers:
  • Erenumab in migraine
First Posted:
Sep 21, 2021
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marwa Kamal, Principle investigator, Fayoum University
migraine, erenumab,
Additional relevant MeSH terms:
Migraine Disorders
Erenumab

Study Results

No Results Posted as of Sep 21, 2021