STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

Migraine Clinical Trial

Official title:

STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00369499
• Other study ID #: CV05003PC
• Status: Terminated
• Phase: N/A
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 656
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Migraine history of at least 1 year.

• Migraine patients experiencing at least 2 migraine attacks per month.

• Migraine patients experiencing at least 1 migraine attack with aura per month.

• Failure of or intolerance to at least 2 classes of prophylactic migraine medication evaluated in adequate, approved medication trials. At least one of the classes shall come from beta-blockers, anticonvulsants, calcium channel blockers and tricyclic antidepressants.

• Aged 18 - 50 years and of legal age in the host country.

• The patient or legal guardian has signed a study specific informed consent form agreeing to data collection and follow-up requirements.

• The patient agrees to abstain from starting prophylactic migraine medication or agrees to maintain existing prophylactic migraine medication without changing dose or drug from entering the baseline period throughout the duration of the study until final assessments.

• Documented right to left shunt that is suitable for device closure.

Exclusion Criteria:

• Taking migraine preventative medication for conditions other than migraine.

• History of 15 or more headache days per month.

• 8 or more non-migraine headache days per month.

• Overuse of acute headache medication (use on 10 or more days per month).

• Patient has severe central nervous system disease such as seizure disorder, inflammatory disease of the central nervous system, or a previous stroke.

• Previous surgical or device closure of a PFO or ASD.

• Artificial heart valve.

• Pacemaker or ICD implanted within past 3 months.

• Anatomic variant that could affect successful deployment such as coronary sinus, pulmonary veins, Chiari network.

• Uncontrolled bacteremias or dental or surgical procedure within past 30 days or planned within study period.

• Allergy to contrast media, and/or to any component of the device to be used.

• Contraindicated for any medication used during or after the procedure.

• History of atrial fibrillation or atrial flutter (chronic or paroxysmal).

• Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.

• Patient is undergoing dialysis for renal failure.

• Patient has NYHA class 3 or 4 cardiac failure.

• Patient is pregnant, or intends to become pregnant during the trial period.

• Patient requires anticoagulation therapy for a concomitant condition.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• PFO Closure

Locations

Country	Name	City	State
Germany	CardioVascular Center Frankfurt, Sankt Katharinen	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean values of the number of monthly migraine periods, with or without aura.
Secondary	Mean values of monthly migraine frequency with or without aura.
Secondary	Quality of life using a Headache Impact Test Questionnaire.