Migraine DisordersNCT05052008
Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
An observational study of Migraine Disorders, run by Fayoum University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Erenumab
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2020to 10 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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 ,.
Who may be able to join
- -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
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Erenumab
- Keywords
- migraine, erenumab,
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
Erenumab is monoclonal antibody used for management of migraine
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
changes on migraine severity during COVID-19 infection
measuring the severity of migraine attacks on a numerical scale
Measured: during the 6 months
Secondary outcomes (3)
reduction in migraine days
Secondary end points were a 50% or greater reduction in mean migraine days per month
Measured: during the 6 months
rate of using migraine medications
change in the number of days of use of acute migraine-specific medication
Measured: during the 6 months
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
Measured: during the 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Aug 2020
- Primary completion10 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Kamal, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052008
- Sponsor's protocol ID
- Erenumab in migraine
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32758365Garland 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.
PubMed 30813769
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19
- ClinicalTrials.gov ID
- NCT05052008
- Acronym / sponsor ID
- Erenumab in migraine
- Conditions
- Migraine Disorders
- Keywords
- migraine, erenumab,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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 ,.
Key inclusion criteria (7 listed)
- -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
Key exclusion criteria (11 listed)
- Participants are excluded from the study if any of the following criteria apply:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErenumabErenumab is monoclonal antibody used for management of migraine | Drug | – |
Primary outcome
mean number of migraine days
Time frame: 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.
changes on migraine severity during COVID-19 infection
Time frame: during the 6 months
measuring the severity of migraine attacks on a numerical scale
3 secondary outcomes
reduction in migraine days
Time frame: during the 6 months
rate of using migraine medications
Time frame: during the 6 months
assessment of migraine effect on physical activity
Time frame: during the 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Background: PubMed 32758365Schoenen 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.
- Results publication: PubMed 30813769Garland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean number of migraine days (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.