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

NCT05052008 | Completed

• 1 other identifier: Erenumab in migraine
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Migraine Disorders

Keywords

migraine, erenumab,

Outcome Measures

Primary Outcomes (2)

• 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

• changes on migraine severity during COVID-19 infection

  measuring the severity of migraine attacks on a numerical scale

  during the 6 months

Secondary Outcomes (3)

• reduction in migraine days

  during the 6 months

• rate of using migraine medications

  during the 6 months

• assessment of migraine effect on physical activity

  during the 6 months

Interventions

Erenumab DRUG

Erenumab is monoclonal antibody used for management of migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Migraine prevention is an area of a large unmet medical need, with existing prophylactic therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Egyptian adults with chronic migraine (CM). The study consists of a screening period (up to 24 weeks, including at baseline period), a 12-week period and a 24-week period ,.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Marwa Kamal Ahmed Tolba

Al Fayyum, 63111, Egypt

Location

Related Publications (2)

• 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.

  PMID: 32758365 BACKGROUND

• 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.

  PMID: 30813769 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 21, 2021
• Study Start: August 15, 2020
• Primary Completion: August 10, 2021
• Study Completion: September 10, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)