The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Fatty Acid in the Prevention of Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572789
Recruitment Status : Completed
First Posted : October 1, 2020
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Chun-pai Yang, MD, Kuang Tien General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Omega-3 Polyunsaturated Fatty Acids Dietary Supplement: Omega-3 polyunsaturated fatty acids Dietary Supplement: omega-6 PUFAs Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Omega-3 Fatty Acid in the Prevention of Migraine: From the Randomized Clinical Trial to Molecular Biology Approaches
Actual Study Start Date : December 3, 2020
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Dietary Supplement: omega-6 PUFAs
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.
 Dietary Supplement: Omega-3 polyunsaturated fatty acids
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. Migraine Disability Assessment Score (MIDAS) [ Time Frame: 12 weeks ]
    Change of MIDAS scores from baseline to endpoint.

  3. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ]
    Change of HADS scores from baseline to endpoint.

  4. 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.

  5. The Beck Depression Inventory-II (BDI-II) [ Time Frame: 12 weeks ]
    Change of BDI-II scores from baseline to endpoint.

  6. 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).

  7. 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).

  8. Migraine Quality of Life Questionnaire (MSQ) scores [ Time Frame: 12 weeks ]
    Change of Migraine Quality of Life Questionnaire (MSQ) scores from baseline to endpoint.

  9. Pittsburgh Sleep Quality Questionnaire (PSQI) scores [ Time Frame: 12 weeks ]
    Change of Pittsburgh Sleep Quality Questionnaire (PSQI) scores from baseline to endpoint.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

  1. Inclusion Criteria:

    1. Aged 20 to 65 years old
    2. A diagnosis based on the International Classification of Headache Disorders (ICHD-3)
    3. An established migraine history for at least 1 year
    4. Independent from the study
    5. Written informed consent

  2. Exclusion Criteria:

    1. Chronic migraine
    2. Headaches other than migraine

    3. 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
    4. Migraine onset after the age of 50

    5. Emerging abnormal findings on：

      • Laboratory parameters
      • Physical examination
      • Suicidal risks
      • Severe depression
    6. Cognitive impairment
    7. Allergies or hypersensitivity to fish or omega-3 fatty acids
    8. Bleeding diathesis or using anticoagulation agents
    9. Pregnancy or nursing
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572789


Locations
Layout table for location information
Taiwan
Kuang Tien General Hospital
Taichung, Taiwan, 433
Sponsors and Collaborators
Kuang Tien General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chun-Pai Yang, Dr. Neurology department of Kuang Tien General hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chun-pai Yang, MD, Director, Kuang Tien General Hospital
ClinicalTrials.gov Identifier: NCT04572789    
Other Study ID Numbers: 10844
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases