MigraineNCT04572789
Omega-3 Fatty Acid in the Prevention of Migraine
A study testing Omega-3 polyunsaturated fatty acids and omega-6 PUFAs in people with Migraine and Omega-3 Polyunsaturated Fatty Acids, run by Kuang Tien General Hospital at 1 site in Taiwan.
Trial summary
To understand the clinical efficacy for omega-3 PUFAs migraine prevention.To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Omega-3 Polyunsaturated Fatty Acids
- What is being tested?
- Omega-3 polyunsaturated fatty acids and omega-6 PUFAs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2020to 31 Mar 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion Criteria:
- Aged 20 to 65 years old
- A diagnosis based on the International Classification of Headache Disorders (ICHD-3)
- An established migraine history for at least 1 year
- Independent from the study
- Written informed consent
- Exclusion Criteria:
- Chronic migraine
- Headaches other than migraine
- Use any of the following drugs in the past four weeks：
- Migraine prophylaxis agents
- Anti-depressants
- Calcium channel blockers
- Anti-epileptic agents
- Cycle-modulating hormonal drugs
- Onabotulinumtoxin A (Botox) injection
- Migraine onset after the age of 50
- Emerging abnormal findings on：
- Laboratory parameters
- Physical examination
- Suicidal risks
- Severe depression
- Cognitive impairment
- Allergies or hypersensitivity to fish or omega-3 fatty acids
- Bleeding diathesis or using anticoagulation agents
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omega-3 Fatty Acid in the Prevention of Migraine: From the Randomized Clinical Trial to Molecular Biology Approaches
To understand the clinical efficacy for omega-3 PUFAs migraine prevention.To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention.
Read the detailed description
Background:
Migraine is a common disabling disorder and its substantial burden is associated with considerable negative impact on quality of life. Several pharmacological treatments are available for migraine prophylaxis but insufficient efficacy and significant side effects preclude their widely use for migraine treatment. In recent years, more attention has been paid to dietary supplements and natural ingredients for the treatment of migraine. Omega-3 polyunsaturated fatty acids (omega-3 PUFAs) have beneficial on the reduction of neurogenic, perivascular inflammations and pro-inflammatory cytokines, which may play an important role in the pathophysiology of migraine. However, the results of investigations carried out about the clinical efficacy of omega-3 PUFAs in the management of migraine are inconsistent.
Purpose:
To understand the clinical efficacy for omega-3 PUFAs migraine prevention. To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention
Method:
This two-year project includes clinical approaches to investigate the therapeutic effects of omega-3 PUFAs on episodic migraine (4-14 days/month) without migraine preventive treatment in the past one month. 120 patients, aged 20-65, will be randomized in a 12-week, double-blind, placebo-controlled trial comparing the effects of high-dose eicosapentaenoic acid (EPA, 1.8g/day) and placebo intervention. All participants will complete a set of outcome measures: headache questionnaires and headache diary, the Migraine Disability Assessment (MIDAS), patient overall impression questionnaire-migraine improvement questionnaire (PGI-I), patient overall impression questionnaire-migraine severity questionnaire (PGI-S), Beck Depression Inventory-II (BDI-II), Hospital anxiety and depression scale (HADS), Migraine Quality of Life Questionnaire (MSQ), Pittsburgh Sleep Quality Questionnaire (PSQI) at baseline and the follow-up visits before and after 12 weeks of placebo or omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
Expected results:
To establish the clinical evidence of omega-3 PUFAs on migraine prevention. To provide significant insights into molecular actions of omega-3 PUFAs on migraine prevention.
- Conditions
- Migraine, Omega-3 Polyunsaturated Fatty Acids
- Being tested
- Omega-3 polyunsaturated fatty acids, omega-6 PUFAs
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 polyunsaturated fatty acidsDietary supplement
All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
omega-6 PUFAsDietary supplement
All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention. Receives: Dietary Supplement: omega-6 PUFAs |
| Omega-3 | Experimental | All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention. Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of migraine attacks during the 12-week period [Efficacy]
The primary end point is the mean change from baseline (28-day pretreatment period) in the mean number of monthly migraine days during the 12-week period. A migraine day was defined as (a day with headache pain that lasted 4 hours with a peak severity of moderate or severe intensity, or any severity or duration if the participant took and responded to a triptan or ergot) from the second to the fourth diaries compared with the first diary (baseline period).
Measured: 12 weeks
Secondary outcomes (9)
50% reduction of migraine attacks
50% reduction in the the average migraine attacks per month during the 12-week period from baseline (28-day pretreatment period).
Measured: 12 weeks
Migraine Disability Assessment Score (MIDAS)
Change of MIDAS scores from baseline to endpoint.
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Change of HADS scores from baseline to endpoint.
Measured: 12 weeks
The Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S)
Change of PGI-I and PGI-S scores from baseline to endpoint.
Measured: 12 weeks
The Beck Depression Inventory-II (BDI-II)
Change of BDI-II scores from baseline to endpoint.
Measured: 12 weeks
Reduction of acute headache medications
Reduction from baseline in the number of days with acute headache medications, from the second to the fourth diaries compared with the first diary (baseline period).
Measured: 12 weeks
Reduction of accumulative headache hours
Reduction in accumulative headache hours from the second to the fourth diaries compared with the first diary (baseline period).
Measured: 12 weeks
Migraine Quality of Life Questionnaire (MSQ) scores
Change of Migraine Quality of Life Questionnaire (MSQ) scores from baseline to endpoint.
Measured: 12 weeks
Pittsburgh Sleep Quality Questionnaire (PSQI) scores
Change of Pittsburgh Sleep Quality Questionnaire (PSQI) scores from baseline to endpoint.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start3 Dec 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-pai Yang, MD, Kuang Tien General Hospital
- Investigators
- Chun-Pai Yang, Dr., Principal investigator, Neurology department of Kuang Tien General hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572789
- Sponsor's protocol ID
- 10844
- Status last verified
- Jun 2022
- First submitted
- 23 Sep 2020
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid in the Prevention of Migraine: From the Randomized Clinical Trial to Molecular Biology Approaches
- ClinicalTrials.gov ID
- NCT04572789
- Acronym / sponsor ID
- 10844
- Conditions
- Migraine, Omega-3 Polyunsaturated Fatty Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Oct 2020 (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.
To understand the clinical efficacy for omega-3 PUFAs migraine prevention.To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention.
Detailed description
Background:
Migraine is a common disabling disorder and its substantial burden is associated with considerable negative impact on quality of life. Several pharmacological treatments are available for migraine prophylaxis but insufficient efficacy and significant side effects preclude their widely use for migraine treatment. In recent years, more attention has been paid to dietary supplements and natural ingredients for the treatment of migraine. Omega-3 polyunsaturated fatty acids (omega-3 PUFAs) have beneficial on the reduction of neurogenic, perivascular inflammations and pro-inflammatory cytokines, which may play an important role in the pathophysiology of migraine. However, the results of investigations carried out about the clinical efficacy of omega-3 PUFAs in the management of migraine are inconsistent.
Purpose:
To understand the clinical efficacy for omega-3 PUFAs migraine prevention. To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention
Method:
This two-year project includes clinical approaches to investigate the therapeutic effects of omega-3 PUFAs on episodic migraine (4-14 days/month) without migraine preventive treatment in the past one month. 120 patients, aged 20-65, will be randomized in a 12-week, double-blind, placebo-controlled trial comparing the effects of high-dose eicosapentaenoic acid (EPA, 1.8g/day) and placebo intervention. All participants will complete a set of outcome measures: headache questionnaires and headache diary, the Migraine Disability Assessment (MIDAS), patient overall impression questionnaire-migraine improvement questionnaire (PGI-I), patient overall impression questionnaire-migraine severity questionnaire (PGI-S), Beck Depression Inventory-II (BDI-II), Hospital anxiety and depression scale (HADS), Migraine Quality of Life Questionnaire (MSQ), Pittsburgh Sleep Quality Questionnaire (PSQI) at baseline and the follow-up visits before and after 12 weeks of placebo or omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
Expected results:
To establish the clinical evidence of omega-3 PUFAs on migraine prevention. To provide significant insights into molecular actions of omega-3 PUFAs on migraine prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: omega-6 PUFAsAll participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention. |
| Omega-3 | Experimental | Dietary Supplement: Omega-3 polyunsaturated fatty acidsAll participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Omega-3 polyunsaturated fatty acidsAll participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention. | Dietary supplement | Omega-3 |
| omega-6 PUFAsAll participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention. | Dietary supplement | placebo |
Primary outcome
Reduction of migraine attacks during the 12-week period [Efficacy]
Time frame: 12 weeks
The primary end point is the mean change from baseline (28-day pretreatment period) in the mean number of monthly migraine days during the 12-week period. A migraine day was defined as (a day with headache pain that lasted 4 hours with a peak severity of moderate or severe intensity, or any severity or duration if the participant took and responded to a triptan or ergot) from the second to the fourth diaries compared with the first diary (baseline period).
9 secondary outcomes
50% reduction of migraine attacks
Time frame: 12 weeks
Migraine Disability Assessment Score (MIDAS)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
The Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S)
Time frame: 12 weeks
The Beck Depression Inventory-II (BDI-II)
Time frame: 12 weeks
Reduction of acute headache medications
Time frame: 12 weeks
Reduction of accumulative headache hours
Time frame: 12 weeks
Migraine Quality of Life Questionnaire (MSQ) scores
Time frame: 12 weeks
Pittsburgh Sleep Quality Questionnaire (PSQI) scores
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Chun-Pai Yang, Dr. principal investigator
Neurology department of Kuang Tien General hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 polyunsaturated fatty acids and omega-6 PUFAs in people with Migraine and Omega-3 Polyunsaturated Fatty Acids, run by Kuang Tien General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 23 Jun 2022. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of migraine attacks during the 12-week period [Efficacy] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2022.