NCT05079659

Brief Summary

Nowadays, headache has been considered as one of the top global disabling medical conditions.1 Migraine is an important type of headache, and one of the chronic multifaceted neuro-inflammatory disorders.2 It is characterized by recurrent throbbing headache pain that typically affects one side of the head, and is often accompanied by nausea and disturbed vision. Migraine headache accounts for 1.4% of all neurological and mental disorders.2 It was reported that the estimated lifetime prevalence of migraine ranged 12%-18%.3 Chronic migraine is defined by the International Classification of Headache Disorders - ICHD-3 as having headaches for ≥ 15 days per month, for ≥ 3 months , which ≥ 8 days/month are linked to migraine. Chronic migraine affects around 1%-4% of the population and chronic tension-type headache about 2.2%.4 Approximately 25%-50% of those affected also have medication overuse headache, which has a population prevalence of 1%.5 Chronic headache is a severely disabling long-term condition, with higher symptom ,frequency and severity than episodic headache.6

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

September 28, 2021

Last Update Submit

October 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess remission rate of chronic migraine to episodic migraine

    by assessing cases which remit from chronic migraine to episodic migraine according to the criteria of each of them

    2 years

Secondary Outcomes (1)

  • to assess potential predictors of chronic migraine

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

sample size was calculated using epidemiological information statistical package version 7. Based on paramaters for cross sectional study;proportion of remitted migraine .26 ,acceptable margin of error 0.05 ,design effect1.95% confidence level. The required sample size will be 296 migrainous patient .

You may qualify if:

  • both sex 2- all age groups are included 3-history suggestive of chronic migraine 4-accept to participate in the study

You may not qualify if:

  • presence of neurological disease other than chronic migraine 2-presence of other chronic medical conditions 3-patients refuse to participate in the study .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (8)

  • Noor T, Sajjad A, Asma A. Frequency, character and predisposing factor of headache among students of medical college of Karachi. J Pak Med Assoc. 2016 Feb;66(2):159-64.

    PMID: 26819160BACKGROUND
  • van Hemert S, Breedveld AC, Rovers JM, Vermeiden JP, Witteman BJ, Smits MG, de Roos NM. Migraine associated with gastrointestinal disorders: review of the literature and clinical implications. Front Neurol. 2014 Nov 21;5:241. doi: 10.3389/fneur.2014.00241. eCollection 2014.

    PMID: 25484876BACKGROUND
  • Semiz M, Senturk IA, Balaban H, Yagiz AK, Kavakci O. Prevalence of migraine and co-morbid psychiatric disorders among students of Cumhuriyet University. J Headache Pain. 2013 Apr 11;14(1):34. doi: 10.1186/1129-2377-14-34.

    PMID: 23578213BACKGROUND
  • Ibrahim N, Al-Kharboush D, El-Khatib L, Al-Habib A, Asali D. Prevalence and Predictors of Anxiety and Depression among Female Medical Students in King Abdulaziz University, Jeddah, Saudi Arabia. Iran J Public Health. 2013 Jul 1;42(7):726-36. eCollection 2013.

    PMID: 24427751BACKGROUND
  • Cousins G, Hijazze S, Van de Laar FA, Fahey T. Diagnostic accuracy of the ID Migraine: a systematic review and meta-analysis. Headache. 2011 Jul-Aug;51(7):1140-8. doi: 10.1111/j.1526-4610.2011.01916.x. Epub 2011 Jun 7.

    PMID: 21649653BACKGROUND
  • Bigal ME, Serrano D, Buse D, Scher A, Stewart WF, Lipton RB. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008 Sep;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x.

    PMID: 18808500BACKGROUND
  • Manack A, Buse DC, Serrano D, Turkel CC, Lipton RB. Rates, predictors, and consequences of remission from chronic migraine to episodic migraine. Neurology. 2011 Feb 22;76(8):711-8. doi: 10.1212/WNL.0b013e31820d8af2. Epub 2011 Jan 26.

    PMID: 21270413BACKGROUND
  • McKenna SP, Doward LC, Davey KM. The Development and Psychometric Properties of the MSQOL: A Migraine-Specific Quality-of-Life Instrument. Clin Drug Investig. 1998;15(5):413-23. doi: 10.2165/00044011-199815050-00006.

    PMID: 18370497BACKGROUND

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

mostafa omar, master

CONTACT

tarek rageh, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 15, 2021

Study Start

January 1, 2021

Primary Completion

April 1, 2023

Study Completion

August 30, 2023

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations