Clinical trial NCT05052008: Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
Official title: Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Keywords: migraine, erenumab,
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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 ,.

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

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

Primary outcomes:
measure: mean number of migraine days
timeFrame: 6 months
measure: changes on migraine severity during COVID-19 infection
timeFrame: during the 6 months
Secondary outcomes:
measure: reduction in migraine days
timeFrame: during the 6 months
measure: rate of using migraine medications
timeFrame: during the 6 months
measure: assessment of migraine effect on physical activity
timeFrame: during the 6 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Marwa Kamal Ahmed Tolba
Study officials:
References:
citation: 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.
citation: 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.