| - candidate number | 2483 |
| - NTR Number | NTR917 |
| - ISRCTN | ISRCTN54702843 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 20-feb-2007 |
| - Secondary IDs | |
| - Public Title | STOP PAIN |
| - Scientific Title | Septal closure of PFO- does it prevent migraine? |
| - ACRONYM | STOP PAIN |
| - hypothesis | The 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) studied | Migraine, Foramen ovale persistens, Closure |
| - Inclusion criteria | 1. 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 criteria | 1. 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 received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-apr-2008 |
| - Target number of participants | 50 |
| - Interventions | In migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomization will be performed or sham procedure |
| - Primary outcome | Number of patients experiencing 50% reduction of migraine in closure group compared with sham group. |
| - Secondary outcome | Mean values of monthly migraine periods QoL using headache impact test questionaire. |
| - Timepoints | |
| - Trial web site | http://www.pfo-lumc.nl |
| - status | stopped |
| - 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 summary | The 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) | |
| - RECORD | 20-feb-2007 - 12-dec-2011 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl