Copy Number Variation in CHRNA7 Gene in Migraine and Gene... | NCT04912752

Studies
Copy Number Variation in CHRNA7 Gene in Migraine and Gene Expression

NCT04912752

Sponsor

University of Gaziantep

Status

Completed

Last Update Posted

Jun 3, 2021Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Migraine

Interventions

Migraine CNV

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2020Actual

Primary Completion Date

Dec 10, 2020Actual

Completion Date

Jan 2, 2021Actual

First Submitted Date

May 21, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2021

Last Update Posted Date

Jun 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case-Control	Other	Copy number variation	Genetic: Migraine CNV
Case-Control 1	Experimental	Gene expression	Genetic: Migraine CNV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Migraine CNV	Genetic	Copy number variation effect on migraine disease	Case-Control Case-Control 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CNV number	CNV number effect on migraine	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Migraine

Exclusion Criteria:

Vascular problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehmet Fatih Özaltun, MD	Assist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicine		Gaziantep	Şehitkamil	27310	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

manuscript not yet published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided