Migraine Clinical Trial
Official title:
Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.
Status | Recruiting |
Enrollment | 242 |
Est. completion date | December 1, 2025 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Age 18-65 ; 2. Diagnosed migraine by ICHD-3 3. History of migraine longer than 1 year, and symptoms severely disturbing daily life. 4. TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt 5. Willing to participant and agree to follow-ups 6. Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%. Exclusion Criteria: 1. Migraine caused by other reason 2. Had TIA/stroke history 3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs. 4. With contraindication to PFO occlusion |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences, Fuwai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responder rate | Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase. | From baseline period to 12-month treatment period | |
Secondary | Migraine days change per month | Change in the mean number of migraine days from baseline to treatment phase. | From baseline period to 12-month treatment period | |
Secondary | Number of migraine attacks change per month | Change in the mean number of migraine attacks from baseline to treatment phase. | From baseline period to 12-month treatment period | |
Secondary | Percentage of complete migraine cessation | Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase. | From baseline period to 12-month treatment period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
Recruiting |
NCT03832998 -
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
|
Phase 3 | |
Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
Completed |
NCT06304675 -
Manageable Environmental Factors in Migraine
|
||
Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
Completed |
NCT04179474 -
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
|
Phase 1 | |
Recruiting |
NCT04603976 -
Registry for Migraine - Clinical Core
|
Phase 4 | |
Completed |
NCT03597529 -
CHOCOlate MeLatonin for AdolescenT MigrainE
|
Phase 2 | |
Completed |
NCT04197349 -
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
|
Phase 1 | |
Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
Active, not recruiting |
NCT05064371 -
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
|
Phase 3 | |
Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
Not yet recruiting |
NCT04859374 -
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
|
N/A | |
Not yet recruiting |
NCT03083860 -
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
N/A | |
Completed |
NCT02905227 -
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
|
Phase 1 | |
Enrolling by invitation |
NCT02532023 -
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
|
Phase 4 | |
Completed |
NCT02108678 -
One-Day Intervention for Depression and Impairment in Migraine Patients
|
N/A |