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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052008
• Other study ID #: Erenumab in migraine
• Status: Completed
• Start date: August 15, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: September 2021
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 10, 2021
• Est. primary completion date: August 10, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Erenumab
Erenumab is monoclonal antibody used for management of migraine

Locations

Country	Name	City	State
Egypt	Marwa Kamal Ahmed Tolba	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View Citation

Schoenen J, Manise M, Nonis R, Gérard 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean number of migraine days	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
Primary	changes on migraine severity during COVID-19 infection	measuring the severity of migraine attacks on a numerical scale	during the 6 months
Secondary	reduction in migraine days	Secondary end points were a 50% or greater reduction in mean migraine days per month	during the 6 months
Secondary	rate of using migraine medications	change in the number of days of use of acute migraine-specific medication	during the 6 months
Secondary	assessment of migraine effect on physical activity	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