Clinical trial NCT04572789: Omega-3 Fatty Acid in the Prevention of Migraine
Official title: Omega-3 Fatty Acid in the Prevention of Migraine: From the Randomized Clinical Trial to Molecular Biology Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Omega-3 Polyunsaturated Fatty Acids
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Reduction of migraine attacks during the 12-week period [Efficacy]
timeFrame: 12 weeks
Secondary outcomes:
measure: 50% reduction of migraine attacks
timeFrame: 12 weeks
measure: Migraine Disability Assessment Score (MIDAS)
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: The Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S)
timeFrame: 12 weeks
measure: The Beck Depression Inventory-II (BDI-II)
timeFrame: 12 weeks
measure: Reduction of acute headache medications
timeFrame: 12 weeks
measure: Reduction of accumulative headache hours
timeFrame: 12 weeks
measure: Migraine Quality of Life Questionnaire (MSQ) scores
timeFrame: 12 weeks
measure: Pittsburgh Sleep Quality Questionnaire (PSQI) scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
Study officials:
affiliation: Neurology department of Kuang Tien General hospital
name: Chun-Pai Yang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: