Migraine Prophylaxis With Clopidogrel Trial

Migraine Clinical Trial

Official title:

A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02938182
• Other study ID #: XJTU1AF-CRS-2016-019
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: October 2023

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guogang Luo, doctor
• Phone: 0086-13991974085
• Email: lguogang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Description:

Many studies have shown an increased prevalence of right-to-left shunts in migraineurs. The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. In the present study, migraineurs without taking prophylactic medicines regularly will be given only clopidogrel 75 mg daily for three months. Migraineurs who are unresponsive to at least two commonly applied preventive medications, clopidogrel 75 mg daily will be added to his/her existing prophylactic migraine regimen for three months. Patients will be followed up at the third month and the sixth month for headache frequency, attack duration of headache, migraine disability assessment scale（MIDAS）scores, headache impact test（HIT-6）scores and visual analogue scale（VAS）scores. Investigators will evaluate the changes of these measurements between baseline and the follow-up time. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• migraine with or without aura diagnosed by a neurologist according to the criteria of the International Headache Society (3nd edition)
• experience a minimum of two migraine attacks per month in a 3-month baseline phase
• without regular use of prophylactic treatments or unresponsive to two and more commonly applied preventive medications
• the presence of RLS confirmed by contrast-enhanced transcranial Doppler
• no positive findings in cranial CT and MRI

Exclusion Criteria:

• other types of headaches
• systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
• history of head injury
• other contraindications to clopidogrel treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• clopidogrel
clopidogrel troche 75 mg daily for three months

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Attack Duration of Headache at three months, h		three months
Secondary	Change from Baseline Headache Frequency per Month at three months, time		three months
Secondary	Change from Baseline Visual Analogue Scale at three months, scores		three months
Secondary	Change from Baseline Migraine Disability Assessment Scale at three months, scores		three months
Secondary	Change from Baseline Headache Impact Test at three months, scores		three months