PRIMA PFO Migraine Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00505570
• Date of registration: 20/07/2007
• Primary sponsor: AGA Medical Corporation
• Public title: PRIMA PFO Migraine Trial PRIMA
• Scientific title: Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
• Date of first enrolment: May 2006
• Target sample size: 144
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00505570
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Canada, Germany, Switzerland, United Kingdom

Contacts

• Name: Prima Trial Steering Committee

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who are age 18 to 65

- Subjects who have migraine headaches with aura diagnosed by a doctor

- Subjects who have not responded to or cannot take common migraine preventive
medications

Exclusion Criteria:

- Subjects with a clinical history of stroke

- Subjects who cannot take aspirin and clopidogrel (Plavix)

- Subjects who are pregnant or desire to become pregnant within the next year



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine

Migraine With Aura

Patent Foramen Ovale

PFO

Intervention(s)

Device: AMPLATZER® PFO Occluder Device

Primary Outcome(s)

Migraine headache frequency [Time Frame: 12 months]

Secondary Outcome(s)

Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure [Time Frame: 12 months]

Secondary ID(s)

AGA010E

Source(s) of Monetary Support

Please refer to primary and secondary sponsors