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

Completed

• Conditions: Migraine Disorders

• Registration Number: NCT05052008
• Lead Sponsor: Fayoum University

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

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 Timeline

• Study Start: 2020-08-15
• Primary Completion: 2021-08-10
• Status Verified: 2021-09
• Study Completion: 2021-09-10
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Study First Posted: 2021-09-21
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes on migraine severity during COVID-19 infection	during the 6 months	measuring the severity of migraine attacks on a numerical scale
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.

Secondary Outcome Measures

Name	Time	Method
rate of using migraine medications	during the 6 months	change in the number of days of use of acute migraine-specific medication
reduction in migraine days	during the 6 months	Secondary end points were a 50% or greater reduction in mean migraine days per month
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

Trial Locations

Locations (1)

Marwa Kamal Ahmed Tolba; 🇪🇬 Fayoum, Egypt