MigraineNCT04912752
Copy Number Variation in CHRNA7 Gene in Migraine and Gene Expression
A study testing Migraine CNV in people with Migraine, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Migraine is a common and possible hereditary disease. Copy number variation (CNV) is a phenomenon in which parts of the genome are repeated and the number of repeats in the genome varies between individuals in the human population.The CHRNA7 gene has a major role in the neuropsychiatric phenotypes observed in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Migraine CNV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2020to 2 Jan 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Migraine
Who cannot join
- Vascular problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Copy Number Variation in Migraine and Gene Expression
Migraine is a common and possible hereditary disease. Copy number variation (CNV) is a phenomenon in which parts of the genome are repeated and the number of repeats in the genome varies between individuals in the human population.The CHRNA7 gene has a major role in the neuropsychiatric phenotypes observed in patients. The 15q13.3 gain/loss variation in this gene may be associated with migraine.
Read the detailed description
Migraine is a common neurological disorder. Although they have different genetic bases according to their types, cholinergic receptors after calcium channels play an important role in the clinic and genetics of the disease. Neuronal acetylcholine receptor subunit alpha-7, also known as nAChRα7, is a protein that in humans is encoded by the CHRNA7 gene.
- Conditions
- Migraine
- Being tested
- Migraine CNV
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migraine CNVGenetic
Copy number variation effect on migraine disease
| Study group | Role | What they receive |
|---|---|---|
| Case-Control | Other | Copy number variation Receives: Genetic: Migraine CNV |
| Case-Control 1 | Experimental | Gene expression Receives: Genetic: Migraine CNV |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNV number
CNV number effect on migraine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start5 Apr 2020
- Primary completion10 Dec 2020
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay Görücü Yılmaz, University of Gaziantep
- Investigators
- Mehmet Fatih Özaltun, MD, Principal investigator, Assist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912752
- Sponsor's protocol ID
- 2020/12
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: manuscript not yet published
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copy Number Variation in Migraine and Gene Expression
- ClinicalTrials.gov ID
- NCT04912752
- Acronym / sponsor ID
- 2020/12
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 3 Jun 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.
Migraine is a common and possible hereditary disease. Copy number variation (CNV) is a phenomenon in which parts of the genome are repeated and the number of repeats in the genome varies between individuals in the human population.The CHRNA7 gene has a major role in the neuropsychiatric phenotypes observed in patients. The 15q13.3 gain/loss variation in this gene may be associated with migraine.
Detailed description
Migraine is a common neurological disorder. Although they have different genetic bases according to their types, cholinergic receptors after calcium channels play an important role in the clinic and genetics of the disease. Neuronal acetylcholine receptor subunit alpha-7, also known as nAChRα7, is a protein that in humans is encoded by the CHRNA7 gene.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case-Control | Other | Genetic: Migraine CNVCopy number variation |
| Case-Control 1 | Experimental | Genetic: Migraine CNVGene expression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Migraine
Key exclusion criteria (1 listed)
- Vascular problems
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 |
|---|---|---|
| Migraine CNVCopy number variation effect on migraine disease | Genetic | Case-Control, Case-Control 1 |
Primary outcome
CNV number
Time frame: 1 year
CNV number effect on migraine
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 3 Jun 2021.
- Individual participant dataSharing planned: No. manuscript not yet published
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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.
Mehmet Fatih Özaltun, MD principal investigator
Assist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Migraine CNV in people with Migraine, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 3 Jun 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 Turkey (Türkiye). 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?
CNV number (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2021.