Episodic MigraineE-MigraNCT04828941
My Healthy Diary - An Electronic Diary for Remote Migraine Monitoring
A study testing Electronic Headache Diary and Paper Diary in people with Episodic Migraine and Migraine Disorders, run by Unidade Local de Saúde de Matosinhos, EPE at 1 site in Portugal.
Trial summary
This study aims to evaluate the usefulness of an app-based headache diary in episodic migraine patients. For this the investigators will conduct a randomized clinical trial with a crossover design, using the app-based diary and a traditional paper-based headache diary. The patients will use each diary for 13 weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Episodic Migraine, Migraine Disorders
- What is being tested?
- Electronic Headache Diary and Paper Diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 28 Mar 2021to 1 Nov 2021
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with episodic migraine, diagnosed for more than 6 months.
- Patients with at least 4 headache days per month and a maximum of 15 headache days per month.
Who cannot join
- Patients with major psychiatric illness.
- Patients participating in another clinical trial.
- Patients who do not meet diagnostic criteria for episodic migraine according to ICHD-3.
- Illiterate patients or those who are unable to fill the records independently.
- Patients with a previous history of filling in a headache calendar, in the 3 months prior to randomization.
- Patients who do not use a cell phone with Android OS.
- Patients who cannot read or write in Portuguese.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Pedro Hispano, Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Porto District, 4464-513
Axel Ferreira, MD, 926491618, axelferr@gmail.com
About this study
Official title: A 26-week Randomized Clinical Trial of an Electronic Headache Diary in Migraine Patients
This study aims to evaluate the usefulness of an app-based headache diary in episodic migraine patients. For this the investigators will conduct a randomized clinical trial with a crossover design, using the app-based diary and a traditional paper-based headache diary. The patients will use each diary for 13 weeks. The investigators will evaluate diary adhesion after each 13-week period, and also evaluate headache burden and prophylactic medication compliance at the beginning, at the crossover point, and at the end of the study, and acute headache medication use through diary records. The investigators will also evaluate user preference through a questionnaire at the end of the study.
Read the detailed description
Headache is one of the main reasons for seeking primary health care and an important cause of absenteeism at work and decreased quality of life in the population, being the major neurological cause of disability in young adults and middle-aged adults. Although the subjectivity of the complaints and the great intra and inter-individual variability of clinical presentations hinder its epidemiological study, it is estimated that the overall prevalence of headache throughout life is 66% (46-78% in tension-type headache; 14-16% for migraine and 0.1-0.3% for cluster headache). Migraine, in particular, is a primary headache with an estimated prevalence of 11 to 14% in adult women and 4 to 9% in adult men. In addition, it is assumed that up to 20% of absences from work can be attributed to headaches, with the inherent socio-economic impacts.
Headache is a very frequent complaint in the primary care setting. However, the differential diagnosis can be complicated at this level. Primary headache diagnosis is made almost exclusively through clinical history taking, for this purpose clinicians use the criteria in the International Classification of Headache Disorders, currently on its 3rd version. However, its application is often challenging and time-consuming, especially in a primary care setting, where physicians are very limited on time. Nonetheless, a correct diagnosis is essential, as treatment varies among the primary headaches and also within the same headache type according to its frequency.
The episodic nature of headaches increases the risk of memory bias towards more severe or more recent crises. To avoid this, patients nowadays use a paper calendar. This calendar makes it possible to monitor, more reliably, the response to therapy and to identify the need for any adjustments.
However, the paper calendar has many limitations, such as the possibility of filling in immediately before consultations instead of non-biased daily records. In addition, the paper or card used can be lost, is more easily forgotten, and cannot be consulted remotely by the attending physician. In the current digital landscape, we have seen a transition in registration methods for semi-automated electronic platforms, considered more practical and appealing to users. However, most in-app headache diaries are not validated and are mainly written in English.
Having these ideas in mind the investigators decided to develop an app-based electronic headache diary that would not only permit a better adhesion to follow-up but also remote monitoring of headache patients. To study the applicability and the usefulness of this idea the investigators designed a randomized clinical trial with a crossover design where episodic migraine patients would be randomized to the use of the app or of a paper headache diary. Each patient would use the app and the paper diary for a period of 13 weeks.
In the paper and electronic diary patients will record headache days, headache type (migraine or tension-type headache), headache intensity with a scale from 0 to 10, intake of acute headache medication, missing work days due to headache, and recurrence to the emergency department due to headache.
The investigators will also measure headache burden with the portuguese versions of HIT-6, MSQ v2.1 and MiDAS scales and quality of life with the WHOQOL-BREF at the beginning, at the crossover point, and at the end of the study. Also, the study will evaluate prophylactic medication compliance at the beginning, at the crossover point, and at the end of the study through a questionnaire. User preference will be measured through a questionnaire, using a Likert type scale, at the end of the study.
- Conditions
- Episodic Migraine, Migraine Disorders
- Being tested
- Electronic Headache Diary, Paper Diary
- Keywords
- Migraine Disorders, mHealth, Mobile Applications, Health Diaries
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Headache DiaryDevice
The electronic headache diary is an app-based diary that permits the registration of headaches, their acute treatment and their associated work incapacity. It also permits real-time monitoring of these data.
Paper DiaryDevice
The paper diary permits the registration of the same variables as the electronic diary in paper format.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Headache Diary | Experimental | The electronic headache diary registers: total number of days with headache per month, number of days with migraine per month, number of days with tension headache per month, number of days taking SOS medication per month, number of days with incapacity for work per month, number of days in which patient goes to the emergency department. Receives: Device: Electronic Headache Diary |
| Paper Diary | Active comparator | The paper headache diary registers: total number of days with headache per month, number of days with migraine per month, number of days with tension headache per month, number of days taking SOS medication per month, number of days with incapacity for work per month, number of days in which patient goes to the emergency department. Receives: Device: Paper Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary compliance
To assess whether the compliance of migraine patients to the use of an electronic headache diary is superior to adherence to the paper diary. The quantification of adherence will be made in: 1.1.) % Of days per month of headache registration; and 1.2.) % of patients who abandon calendar registration at 13 weeks.
Measured: 6 months
Secondary outcomes (9)
Patient Preference
Preference of the patient for one of the diaries measured through a questionnaire.
Measured: 6 months
Quality of Life (HIT-6)
Comparison of the quality of life using data from HIT-6 evaluated at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Quality of Life (MSQ v2.1)
Comparison of the quality of life using data from MSQ v2.1 evaluated at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Quality of Life (WHOQOL-BREF)
Comparison of the quality of life using data from WHOQOL-BREF evaluated at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Incapacity Days
Comparison of the number of incapacity days using data from the diaries and from MiDAS evaluated at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Subjective Evaluation of the Number of Headache Days
Comparison of the patient's subjective evaluation of the number of headache days using data from questionnaires evaluated at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Number of Acute Headache Medication Use Days
Comparison of the number of acute headache medication use days using data from the diaries and questionnaires filled at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Prophylactic Medication Compliance
Comparison of the number of days of prophylactic medication noncompliance evaluated by questionnaire at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Emergency Department Visits
Comparison of the number of emergency department visits evaluated by data collected from the diaries and a questionnaire filled at the baseline, after using the electronic diary and after using the paper diary.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start28 Mar 2021 (estimated)
- Primary completion2 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will use the electronic headache diary and the paper diary for a period of 13 weeks, the order of their use will be determined by randomisation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Matosinhos, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Ferreira, Unidade Local de Saúde de Matosinhos, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828941
- Sponsor's protocol ID
- 96/CE/JAS
- Acronym
- E-Migra
- Status last verified
- Mar 2021
- First submitted
- 27 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015 Aug;61(8):670-9.
PubMed 26273080Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
PubMed 17381554GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
PubMed 30879893Nappi G, Jensen R, Nappi RE, Sances G, Torelli P, Olesen J. Diaries and calendars for migraine. A review. Cephalalgia. 2006 Aug;26(8):905-16. doi: 10.1111/j.1468-2982.2006.01155.x.
PubMed 16886925Baos V, Ester F, Castellanos A, Nocea G, Caloto MT, Gerth WC; I-Max Study Group. Use of a structured migraine diary improves patient and physician communication about migraine disability and treatment outcomes. Int J Clin Pract. 2005 Mar;59(3):281-6. doi: 10.1111/j.1742-1241.2005.00469.x.
PubMed 15857323Allena M, Cuzzoni MG, Tassorelli C, Nappi G, Antonaci F. An electronic diary on a palm device for headache monitoring: a preliminary experience. J Headache Pain. 2012 Oct;13(7):537-41. doi: 10.1007/s10194-012-0473-2. Epub 2012 Jul 28.
PubMed 22842873Hundert AS, Huguet A, McGrath PJ, Stinson JN, Wheaton M. Commercially available mobile phone headache diary apps: a systematic review. JMIR Mhealth Uhealth. 2014 Aug 19;2(3):e36. doi: 10.2196/mhealth.3452.
PubMed 25138438Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003 Dec;12(8):963-74. doi: 10.1023/a:1026119331193.
PubMed 14651415Martin BC, Pathak DS, Sharfman MI, Adelman JU, Taylor F, Kwong WJ, Jhingran P. Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1). Headache. 2000 Mar;40(3):204-15. doi: 10.1046/j.1526-4610.2000.00030.x.
PubMed 10759923Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.
PubMed 11294956Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PubMed 15085902
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week Randomized Clinical Trial of an Electronic Headache Diary in Migraine Patients
- ClinicalTrials.gov ID
- NCT04828941
- Acronym / sponsor ID
- E-Migra / 96/CE/JAS
- Conditions
- Episodic Migraine, Migraine Disorders
- Keywords
- Migraine Disorders, mHealth, Mobile Applications, Health Diaries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Matosinhos, EPEUniversity, hospital or other
- Study start
- 28 Mar 2021 (estimated)
- Primary completion
- 2 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 2 Apr 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.
This study aims to evaluate the usefulness of an app-based headache diary in episodic migraine patients. For this the investigators will conduct a randomized clinical trial with a crossover design, using the app-based diary and a traditional paper-based headache diary. The patients will use each diary for 13 weeks. The investigators will evaluate diary adhesion after each 13-week period, and also evaluate headache burden and prophylactic medication compliance at the beginning, at the crossover point, and at the end of the study, and acute headache medication use through diary records. The investigators will also evaluate user preference through a questionnaire at the end of the study.
Detailed description
Headache is one of the main reasons for seeking primary health care and an important cause of absenteeism at work and decreased quality of life in the population, being the major neurological cause of disability in young adults and middle-aged adults. Although the subjectivity of the complaints and the great intra and inter-individual variability of clinical presentations hinder its epidemiological study, it is estimated that the overall prevalence of headache throughout life is 66% (46-78% in tension-type headache; 14-16% for migraine and 0.1-0.3% for cluster headache). Migraine, in particular, is a primary headache with an estimated prevalence of 11 to 14% in adult women and 4 to 9% in adult men. In addition, it is assumed that up to 20% of absences from work can be attributed to headaches, with the inherent socio-economic impacts.
Headache is a very frequent complaint in the primary care setting. However, the differential diagnosis can be complicated at this level. Primary headache diagnosis is made almost exclusively through clinical history taking, for this purpose clinicians use the criteria in the International Classification of Headache Disorders, currently on its 3rd version. However, its application is often challenging and time-consuming, especially in a primary care setting, where physicians are very limited on time. Nonetheless, a correct diagnosis is essential, as treatment varies among the primary headaches and also within the same headache type according to its frequency.
The episodic nature of headaches increases the risk of memory bias towards more severe or more recent crises. To avoid this, patients nowadays use a paper calendar. This calendar makes it possible to monitor, more reliably, the response to therapy and to identify the need for any adjustments.
However, the paper calendar has many limitations, such as the possibility of filling in immediately before consultations instead of non-biased daily records. In addition, the paper or card used can be lost, is more easily forgotten, and cannot be consulted remotely by the attending physician. In the current digital landscape, we have seen a transition in registration methods for semi-automated electronic platforms, considered more practical and appealing to users. However, most in-app headache diaries are not validated and are mainly written in English.
Having these ideas in mind the investigators decided to develop an app-based electronic headache diary that would not only permit a better adhesion to follow-up but also remote monitoring of headache patients. To study the applicability and the usefulness of this idea the investigators designed a randomized clinical trial with a crossover design where episodic migraine patients would be randomized to the use of the app or of a paper headache diary. Each patient would use the app and the paper diary for a period of 13 weeks.
In the paper and electronic diary patients will record headache days, headache type (migraine or tension-type headache), headache intensity with a scale from 0 to 10, intake of acute headache medication, missing work days due to headache, and recurrence to the emergency department due to headache.
The investigators will also measure headache burden with the portuguese versions of HIT-6, MSQ v2.1 and MiDAS scales and quality of life with the WHOQOL-BREF at the beginning, at the crossover point, and at the end of the study. Also, the study will evaluate prophylactic medication compliance at the beginning, at the crossover point, and at the end of the study through a questionnaire. User preference will be measured through a questionnaire, using a Likert type scale, at the end of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will use the electronic headache diary and the paper diary for a period of 13 weeks, the order of their use will be determined by randomisation.
| Arm | Type | Receives |
|---|---|---|
| Electronic Headache Diary | Experimental | Device: Electronic Headache DiaryThe electronic headache diary registers: total number of days with headache per month, number of days with migraine per month, number of days with tension headache per month, number of days taking SOS medication per month, number of days with incapacity for work per month, number of days in which patient goes to the emergency department. |
| Paper Diary | Active comparator | Device: Paper DiaryThe paper headache diary registers: total number of days with headache per month, number of days with migraine per month, number of days with tension headache per month, number of days taking SOS medication per month, number of days with incapacity for work per month, number of days in which patient goes to the emergency department. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with episodic migraine, diagnosed for more than 6 months.
- Patients with at least 4 headache days per month and a maximum of 15 headache days per month.
Key exclusion criteria (7 listed)
- Patients with major psychiatric illness.
- Patients participating in another clinical trial.
- Patients who do not meet diagnostic criteria for episodic migraine according to ICHD-3.
- Illiterate patients or those who are unable to fill the records independently.
- Patients with a previous history of filling in a headache calendar, in the 3 months prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Headache DiaryThe electronic headache diary is an app-based diary that permits the registration of headaches, their acute treatment and their associated work incapacity. It also permits real-time monitoring of these data. | Device | Electronic Headache Diary |
| Paper DiaryThe paper diary permits the registration of the same variables as the electronic diary in paper format. | Device | Paper Diary |
Primary outcome
Diary compliance
Time frame: 6 months
To assess whether the compliance of migraine patients to the use of an electronic headache diary is superior to adherence to the paper diary. The quantification of adherence will be made in: 1.1.) % Of days per month of headache registration; and 1.2.) % of patients who abandon calendar registration at 13 weeks.
9 secondary outcomes
Patient Preference
Time frame: 6 months
Quality of Life (HIT-6)
Time frame: 6 months
Quality of Life (MSQ v2.1)
Time frame: 6 months
Quality of Life (WHOQOL-BREF)
Time frame: 6 months
Incapacity Days
Time frame: 6 months
Subjective Evaluation of the Number of Headache Days
Time frame: 6 months
Number of Acute Headache Medication Use Days
Time frame: 6 months
Prophylactic Medication Compliance
Time frame: 6 months
Emergency Department Visits
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Background: PubMed 26273080Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015 Aug;61(8):670-9.
- Background: PubMed 17381554Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
- Background: PubMed 30879893GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
- Background: PubMed 16886925Nappi G, Jensen R, Nappi RE, Sances G, Torelli P, Olesen J. Diaries and calendars for migraine. A review. Cephalalgia. 2006 Aug;26(8):905-16. doi: 10.1111/j.1468-2982.2006.01155.x.
- Background: PubMed 15857323Baos V, Ester F, Castellanos A, Nocea G, Caloto MT, Gerth WC; I-Max Study Group. Use of a structured migraine diary improves patient and physician communication about migraine disability and treatment outcomes. Int J Clin Pract. 2005 Mar;59(3):281-6. doi: 10.1111/j.1742-1241.2005.00469.x.
- Background: PubMed 22842873Allena M, Cuzzoni MG, Tassorelli C, Nappi G, Antonaci F. An electronic diary on a palm device for headache monitoring: a preliminary experience. J Headache Pain. 2012 Oct;13(7):537-41. doi: 10.1007/s10194-012-0473-2. Epub 2012 Jul 28.
- Background: PubMed 25138438Hundert AS, Huguet A, McGrath PJ, Stinson JN, Wheaton M. Commercially available mobile phone headache diary apps: a systematic review. JMIR Mhealth Uhealth. 2014 Aug 19;2(3):e36. doi: 10.2196/mhealth.3452.
- Background: PubMed 14651415Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003 Dec;12(8):963-74. doi: 10.1023/a:1026119331193.
- Background: PubMed 10759923Martin BC, Pathak DS, Sharfman MI, Adelman JU, Taylor F, Kwong WJ, Jhingran P. Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1). Headache. 2000 Mar;40(3):204-15. doi: 10.1046/j.1526-4610.2000.00030.x.
- Background: PubMed 11294956Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.
- Background: PubMed 15085902Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Individual participant dataSharing planned: Undecided
Related trials for Episodic Migraine
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
Active, not recruitingPhase 2
A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
Migraine
RecruitingPhase 3
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Episodic Migraine
Active, not recruitingPhase 3
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
Episodic Migraine
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?
A study testing Electronic Headache Diary and Paper Diary in people with Episodic Migraine and Migraine Disorders, run by Unidade Local de Saúde de Matosinhos, EPE at 1 site in Portugal.
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 2 inclusion and 7 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 2 Apr 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 Portugal. 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 Axel Ferreira, MD (+351926491618, axelferr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diary compliance (time frame: 6 months). 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 NCT04828941, which also lists 11 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 2 Apr 2021.