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

This study has been terminated.
(Not enough patients/ ethical concerns)
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00369499
First received: August 28, 2006
Last updated: February 22, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention
Migraine
Device: PFO Closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Mean values of the number of monthly migraine periods, with or without aura.

Secondary Outcome Measures:
  • Mean values of monthly migraine frequency with or without aura.
  • Quality of life using a Headache Impact Test Questionnaire.

Estimated Enrollment: 656
Study Start Date: March 2007
Estimated Study Completion Date: June 2009
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369499

Locations
Germany
CardioVascular Center Frankfurt, Sankt Katharinen
Frankfurt, Germany, 60389
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Michel Ferrari, Prof. Leiden University Medical Centre
Principal Investigator: Horst Sievert, Prof. CardioVascular Center Frankfurt, Sankt Katharinen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00369499     History of Changes
Other Study ID Numbers: CV05003PC
Study First Received: August 28, 2006
Last Updated: February 22, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014