MigraineNCT04659226
MicroRNA Profile and Erenumab Treatment
A study testing Blood sampling for microRNA testing in people with Migraine, run by University of L'Aquila at 1 site in Italy.
Trial summary
Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Blood sampling for microRNA testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 30 Apr 2023
- Phase
- Interventional
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 25 to 50 years
- Chronic or episodic migraine with or without aura diagnosed according to the International Classification of Headache Disorders - 3rd edition
- Receiving a first prescription of erenumab for migraine prevention according to the Summary of Product Characteristics and local reimbursement criteria
- At least 1 year from migraine onset
- Provided informed consent
Who cannot join
- Headache other than migraine
- Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor
- Use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin A
- Pregnant or nursing
- Body Mass Index <18 or >30 Kg/m2
- Heavy smoking (more than 20 cigarettes per day)
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- Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit
- Illicit drug abuse
- Major psychiatric disorders
- Infective or inflammatory diseases
- Any chronic medication prescribed for indications different from migraine within 60 days before study initiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MicroRNA Profile in Women With Migraine Before and After Treatment With Erenumab
Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Migraine is a complex disorder with several genetic and epigenetic influence, including that of microRNA. Several microRNAs, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. Besides, little evidence is available on the role of migraine preventive treatments in the expression of microRNA. The study aims at evaluating the expression profiles of microRNAs before and after erenumab treatment prescribed according to clinical indication. The study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the Summary of Product Characteristics and local reimbursement criteria. The study will compare the expression profile of microRNAs in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.
- Conditions
- Migraine
- Being tested
- Blood sampling for microRNA testing
- Keywords
- cgrp, monoclonal antibodies, microRNA, epigenetic, migraine prevention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for microRNA testingGenetic
Blood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards
| Study group | Role | What they receive |
|---|---|---|
| Episodic or chronic migraine | Experimental | Women starting treatment with erenumab according to clinical indication Receives: Genetic: Blood sampling for microRNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold changes in microRNA serum concentration - Episodic migraine
Relative quantification of circulating microRNAs expression changes in women with episodic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
Measured: 3 months per each patient
Fold changes in microRNA serum concentration - Chronic migraine
Relative quantification of circulating microRNAs expression changes in women with chronic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
Measured: 3 months per each patient
Secondary outcomes (2)
Baseline comparison between episodic and chronic migraine
Relative quantification of microRNA expression levels at baseline in women with chronic compared with episodic migraine. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
Measured: Baseline
Subgroup analyses
Subgroup analyses of patients stratified according to age, migraine characteristics, response to erenumab, and migraine-related impact and disability. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
Measured: 3 months per each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jul 2021
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Simona Sacco, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659226
- Sponsor's protocol ID
- CAMG334AIT05T
- Status last verified
- May 2024
- First submitted
- 5 Nov 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ornello R, Zelli V, Compagnoni C, Caponnetto V, De Matteis E, Tiseo C, Tessitore A, Sacco S. MicroRNA profiling in women with migraine: effects of CGRP-targeting treatment. J Headache Pain. 2024 May 16;25(1):80. doi: 10.1186/s10194-024-01787-2.
PubMed 38755568
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Profile in Women With Migraine Before and After Treatment With Erenumab
- ClinicalTrials.gov ID
- NCT04659226
- Acronym / sponsor ID
- CAMG334AIT05T
- Conditions
- Migraine
- Keywords
- cgrp, monoclonal antibodies, microRNA, epigenetic, migraine prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Dec 2020 (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.
Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Migraine is a complex disorder with several genetic and epigenetic influence, including that of microRNA. Several microRNAs, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. Besides, little evidence is available on the role of migraine preventive treatments in the expression of microRNA. The study aims at evaluating the expression profiles of microRNAs before and after erenumab treatment prescribed according to clinical indication. The study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the Summary of Product Characteristics and local reimbursement criteria. The study will compare the expression profile of microRNAs in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Episodic or chronic migraine | Experimental | Genetic: Blood sampling for microRNA testingWomen starting treatment with erenumab according to clinical indication |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 25 to 50 years
- Chronic or episodic migraine with or without aura diagnosed according to the International Classification of Headache Disorders - 3rd edition
- Receiving a first prescription of erenumab for migraine prevention according to the Summary of Product Characteristics and local reimbursement criteria
- At least 1 year from migraine onset
- Provided informed consent
Key exclusion criteria (11 listed)
- Headache other than migraine
- Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor
- Use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin A
- Pregnant or nursing
- Body Mass Index <18 or >30 Kg/m2
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 |
|---|---|---|
| Blood sampling for microRNA testingBlood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards | Genetic | Episodic or chronic migraine |
Primary outcome
Fold changes in microRNA serum concentration - Episodic migraine
Time frame: 3 months per each patient
Relative quantification of circulating microRNAs expression changes in women with episodic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
Fold changes in microRNA serum concentration - Chronic migraine
Time frame: 3 months per each patient
Relative quantification of circulating microRNAs expression changes in women with chronic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
2 secondary outcomes
Baseline comparison between episodic and chronic migraine
Time frame: Baseline
Subgroup analyses
Time frame: 3 months per each patient
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 29 May 2024.
- Derived from this study: PubMed 38755568Ornello R, Zelli V, Compagnoni C, Caponnetto V, De Matteis E, Tiseo C, Tessitore A, Sacco S. MicroRNA profiling in women with migraine: effects of CGRP-targeting treatment. J Headache Pain. 2024 May 16;25(1):80. doi: 10.1186/s10194-024-01787-2.
- 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?
A study testing Blood sampling for microRNA testing in people with Migraine, run by University of L'Aquila at 1 site in Italy.
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 5 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 29 May 2024. 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 Italy. 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?
Fold changes in microRNA serum concentration - Episodic migraine (time frame: 3 months per each patient). 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 NCT04659226, which also lists 1 linked publication.
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 29 May 2024.