Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04572789
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2020-09-23
Brief Title:
Omega-3 Fatty Acid in the Prevention of Migraine
Sponsor:
Kuang Tien General Hospital
Organization:
Kuang Tien General Hospital
Study Overview
Official Title:
Omega-3 Fatty Acid in the Prevention of Migraine From the Randomized Clinical Trial to Molecular Biology Approaches
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To understand the clinical efficacy for omega-3 PUFAs migraine preventionTo 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 daysmonth 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 18gday 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 18 gday 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
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 daysmonth 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 18gday 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 18 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None