- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572789
Omega-3 Fatty Acid in the Prevention of Migraine
Omega-3 Fatty Acid in the Prevention of Migraine: From the Randomized Clinical Trial to Molecular Biology Approaches
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 433
- Kuang Tien General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
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.
|
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.
|
Experimental: Omega-3
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
50% reduction of migraine attacks
Time Frame: 12 weeks
|
50% reduction in the the average migraine attacks per month during the 12-week period from baseline (28-day pretreatment period).
|
12 weeks
|
Migraine Disability Assessment Score (MIDAS)
Time Frame: 12 weeks
|
Change of MIDAS scores from baseline to endpoint.
|
12 weeks
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 weeks
|
Change of HADS scores from baseline to endpoint.
|
12 weeks
|
The Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S)
Time Frame: 12 weeks
|
Change of PGI-I and PGI-S scores from baseline to endpoint.
|
12 weeks
|
The Beck Depression Inventory-II (BDI-II)
Time Frame: 12 weeks
|
Change of BDI-II scores from baseline to endpoint.
|
12 weeks
|
Reduction of acute headache medications
Time Frame: 12 weeks
|
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).
|
12 weeks
|
Reduction of accumulative headache hours
Time Frame: 12 weeks
|
Reduction in accumulative headache hours from the second to the fourth diaries compared with the first diary (baseline period).
|
12 weeks
|
Migraine Quality of Life Questionnaire (MSQ) scores
Time Frame: 12 weeks
|
Change of Migraine Quality of Life Questionnaire (MSQ) scores from baseline to endpoint.
|
12 weeks
|
Pittsburgh Sleep Quality Questionnaire (PSQI) scores
Time Frame: 12 weeks
|
Change of Pittsburgh Sleep Quality Questionnaire (PSQI) scores from baseline to endpoint.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chun-Pai Yang, Dr., Neurology department of Kuang Tien General hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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