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STOP PAIN


- candidate number2483
- NTR NumberNTR917
- ISRCTNISRCTN54702843
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR20-feb-2007
- Secondary IDs 
- Public TitleSTOP PAIN
- Scientific TitleSeptal closure of PFO- does it prevent migraine?
- ACRONYMSTOP PAIN
- hypothesisThe primary objective of the study ”STOP PAIN” is to compare the effect on migraine attack frequency of transcatheter device closure of atrial shunting with a non-closure group in migraine patients suffering severe migraine with aura.
- Healt Condition(s) or Problem(s) studiedMigraine, Foramen ovale persistens, Closure
- Inclusion criteria1. Migraine with aura; 2. Migraine history of at least 1 year at least 2 migraine attacks/month at least 1 migraine attack with aura; 3. Failure or intolerance to 2 classes prophylactic migraine medication; 4. Aged 18-50; 5. Right to left shunt suitable for closure.
- Exclusion criteria1. History of 15 or more headache days per month; 2. Taking preventive medication for other conditions other than migraine; 3. 8 or more non-migraine headache days/month; 4. Overuse of acute headache medication( use on 10 or more days/month; 5. Severe central nervous system disease previous surgical or device closure of PFO/ASD; 6. Atrial heart valve; 7. Pacemaker or ICD implanted within past 3 months; 8. History of atrial fibrillation; 9. Undergoing dialysis; 10. NYHA class 3 or 4 cardiac failure; 11. Pregnant; 12. Anticoagulation
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2008
- Target number of participants50
- InterventionsIn migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomization will be performed or sham procedure
- Primary outcomeNumber of patients experiencing 50% reduction of migraine in closure group compared with sham group.
- Secondary outcomeMean values of monthly migraine periods QoL using headache impact test questionaire.
- Timepoints
- Trial web sitehttp://www.pfo-lumc.nl
- statusstopped
- CONTACT FOR PUBLIC QUERIES H. Koppen
- CONTACT for SCIENTIFIC QUERIES H. Koppen
- Sponsor/Initiator St Jude Medical inc, Leiden University Medical Center (LUMC), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Neurology, St Jude Medical inc - Belgium
- Publications
- Brief summaryThe primary objective of the study ”STOP PAIN” is to compare the effect on migraine attack frequency of transcatheter device closure of atrial shunting with a non-closure group in migraine patients suffering severe migraine with aura.
- Main changes (audit trail)
- RECORD20-feb-2007 - 12-dec-2011


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