Chronic Migraine, HeadacheNCT05079659
Rate , Predictors and Outcome of Chronic Migraine
An observational study of Chronic Migraine, Headache and Chronic Migraine, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine, Headache, Chronic Migraine
- How many people
- 296 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Aug 2023
- Phase
- Observational
- 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
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 .
Who may be able to join
- 1- both sex 2- all age groups are included 3-history suggestive of chronic migraine 4-accept to participate in the study
Who cannot join
- 1-presence of neurological disease other than chronic migraine 2-presence of other chronic medical conditions 3-patients refuse to participate in the study .
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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 Diagnostic criteria of chronic migraine according to ICHD(7)
Description:
Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache.
Diagnostic criteria:
- Headache (migraine-like or tension-type-like1) on ≥15 days/month for >3 months, and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura
- On ≥8 days/month for >3 months, fulfilling any of the following:
- criteria C and D for 1.1 Migraine without aura
- criteria B and C for 1.2 Migraine with aura
- elieved by the patient to be migraine at onset and relieved by a triptan or ergot derivative D Not better accounted for by another ICHD-3 diagnosis.
Episodic migraine (EM) is characterized by those with migraine who have 0 to 14 headache days per month, while chronic migraine (CM) is characterized by 15 or more headache days per month.
The relationship between EM and CM is complex. EM progresses to CM at the rate of 2.5% per year [8], and CM often remits to EM (2-year transition rate of 26%) [9].
Several factors have been associated with migraine chronification (predictors) ; such as age:
- Age *Sex *Presence of depression *Presence of anxiety
- sleep disorder *obesity *medication compliance *medication overuse
- coffee * low income *allodynia *other pain disordes comorbidities.
Our aims were to identify factors that predict prognosis in patients with chronic Migraine.
- Conditions
- Chronic Migraine, Headache, Chronic Migraine
- Medical subject headings
- Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
to assess potential predictors of chronic migraine
by assessing factors affecting remission of chronic migraine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Omar Abdeaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079659
- Sponsor's protocol ID
- chronic migraine
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26819160van 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.
PubMed 25484876Semiz 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.
PubMed 23578213Ibrahim 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.
PubMed 24427751Cousins 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.
PubMed 21649653Bigal 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.
PubMed 18808500Manack 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.
PubMed 21270413McKenna 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.
PubMed 18370497
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate , Predictors and Outcome of Chronic Migraine
- ClinicalTrials.gov ID
- NCT05079659
- Acronym / sponsor ID
- chronic migraine
- Conditions
- Chronic Migraine, Headache, Chronic Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 15 Oct 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.
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
Detailed description
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 Diagnostic criteria of chronic migraine according to ICHD(7)
Description:
Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache.
Diagnostic criteria:
- Headache (migraine-like or tension-type-like1) on ≥15 days/month for >3 months, and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura
- On ≥8 days/month for >3 months, fulfilling any of the following:
- criteria C and D for 1.1 Migraine without aura
- criteria B and C for 1.2 Migraine with aura
- elieved by the patient to be migraine at onset and relieved by a triptan or ergot derivative D Not better accounted for by another ICHD-3 diagnosis.
Episodic migraine (EM) is characterized by those with migraine who have 0 to 14 headache days per month, while chronic migraine (CM) is characterized by 15 or more headache days per month.
The relationship between EM and CM is complex. EM progresses to CM at the rate of 2.5% per year [8], and CM often remits to EM (2-year transition rate of 26%) [9].
Several factors have been associated with migraine chronification (predictors) ; such as age:
- Age *Sex *Presence of depression *Presence of anxiety
- sleep disorder *obesity *medication compliance *medication overuse
- coffee * low income *allodynia *other pain disordes comorbidities.
Our aims were to identify factors that predict prognosis in patients with chronic Migraine.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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 .
Key inclusion criteria (1 listed)
- 1- both sex 2- all age groups are included 3-history suggestive of chronic migraine 4-accept to participate in the study
Key exclusion criteria (2 listed)
- 1-presence of neurological disease other than chronic migraine 2-presence of other chronic medical conditions 3-patients refuse to participate in the study .
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess remission rate of chronic migraine to episodic migraine
Time frame: 2 years
by assessing cases which remit from chronic migraine to episodic migraine according to the criteria of each of them
1 secondary outcome
to assess potential predictors of chronic migraine
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 26819160Noor 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.
- Background: PubMed 25484876van 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.
- Background: PubMed 23578213Semiz 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.
- Background: PubMed 24427751Ibrahim 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.
- Background: PubMed 21649653Cousins 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.
- Background: PubMed 18808500Bigal 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.
- Background: PubMed 21270413Manack 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.
- Background: PubMed 18370497McKenna 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Migraine, Headache and Chronic Migraine, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa omar, master (01050659948, mostafa189199400@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess remission rate of chronic migraine to episodic migraine (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079659, which also lists 8 linked publications.
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 15 Oct 2021.