STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
This study has been terminated.
(Not enough patients/ ethical concerns)
Information provided by:
St. Jude Medical
First received: August 28, 2006
Last updated: February 22, 2008
Last verified: February 2008
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.
Device: PFO Closure
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
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:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|CardioVascular Center Frankfurt, Sankt Katharinen
|Frankfurt, Germany, 60389 |
St. Jude Medical
||Michel Ferrari, Prof.
||Leiden University Medical Centre
||Horst Sievert, Prof.
||CardioVascular Center Frankfurt, Sankt Katharinen
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 28, 2006
||February 22, 2008
||Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 29, 2014
Central Nervous System Diseases
Headache Disorders, Primary
Nervous System Diseases