Investigating the Frequency and Phenotype of Headaches As... | NCT04804995

Studies
Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.

NCT04804995

Sponsor

Danish Headache Center

Status

Completed

Last Update Posted

Nov 16, 2022Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Headache
Migraine

Interventions

There is no intervention.

Countries

Denmark

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

Nov 2022

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

Mar 16, 2021Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Mar 16, 2021

First Submission Date that Met QC Criteria

Mar 16, 2021

First Posted Date

Mar 18, 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

Nov 15, 2022

Last Update Posted Date

Nov 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heathy participants			Other: There is no intervention.
migraine patients			Other: There is no intervention.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention.	Other	No intervention.	Heathy participants migraine patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Headache frequency	The frequency of headaches is higher in the first half of Ramadan month compared to the last half.	Daily headache diary in three months.
Headache frequency	The frequency of headaches is higher in the month before Ramadan compared to the month after ramadan.	Daily headache diary in three months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-60 years.
expectation of fasting for at least 21 of 30 days during the month of Ramadan.
understand and answer the questionnaire sent out in Danish.

Exclusion Criteria:

non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Healthy participants and migraine patients.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Faisal Mohammad Amin	Danish Headache Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center		Glostrup Municipality		2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided