NCT04804995

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

March 16, 2021

Last Update Submit

November 15, 2022

Conditions

HeadacheMigraine

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Heathy participants

Other: There is no intervention.

migraine patients

Other: There is no intervention.

Interventions

There is no intervention.OTHER

No intervention.

Heathy participantsmigraine patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy participants and migraine patients.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

HeadacheMigraine Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Faisal Mohammad Amin

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

March 16, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)