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

NCT ID: NCT05052008

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2021-09-10

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

Conditions

Migraine Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Erenumab

Erenumab is monoclonal antibody used for management of migraine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Kamal

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marwa Kamal Ahmed Tolba

Al Fayyum, , Egypt

Countries

Egypt

References

Schoenen J, Manise M, Nonis R, Gerard P, Timmermans G. Monoclonal antibodies blocking CGRP transmission: An update on their added value in migraine prevention. Rev Neurol (Paris). 2020 Dec;176(10):788-803. doi: 10.1016/j.neurol.2020.04.027. Epub 2020 Aug 2.

Reference Type: BACKGROUND

PMID: 32758365 (View on PubMed)

Garland SG, Smith SM, Gums JG. Erenumab: A First-in-Class Monoclonal Antibody for Migraine Prevention. Ann Pharmacother. 2019 Sep;53(9):933-939. doi: 10.1177/1060028019835166. Epub 2019 Feb 27.

Reference Type: RESULT

PMID: 30813769 (View on PubMed)

Other Identifiers

Erenumab in migraine

Identifier Type: -

Identifier Source: org_study_id