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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

August 28, 2006
February 22, 2008
March 2007
Not Provided
Mean values of the number of monthly migraine periods, with or without aura.
Same as current
Complete list of historical versions of study NCT00369499 on ClinicalTrials.gov Archive Site
  • Mean values of monthly migraine frequency with or without aura.
  • Quality of life using a Headache Impact Test Questionnaire.
Same as current
Not Provided
Not Provided
 
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Migraine
Device: PFO Closure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
656
June 2009
Not Provided

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00369499
CV05003PC
Not Provided
Not Provided
St. Jude Medical
Not Provided
Principal Investigator: Michel Ferrari, Prof. Leiden University Medical Centre
Principal Investigator: Horst Sievert, Prof. CardioVascular Center Frankfurt, Sankt Katharinen
St. Jude Medical
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP