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.
ID
Bron
Verkorte titel
Aandoening
PFO, migraine, closure
Foramen ovale persistens, migraine, sluiting
Ondersteuning
The corporate village 11- box F1
B-1935 Zaventem
Belgium
0032 27746937
Coordinating clinical investigators: Prof MD Ferrari, Neurology department LUMC
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of patients experiencing 50% reduction of migraine in closure group compared with sham group.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
In migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomization will be performed or sham procedure
Publiek
Postbus 9600
H. Koppen
Leiden 2300 RC
The Netherlands
h.koppen@lumc.nl
Wetenschappelijk
Postbus 9600
H. Koppen
Leiden 2300 RC
The Netherlands
h.koppen@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL893 |
| NTR-old | NTR917 |
| Ander register | : |
| ISRCTN | ISRCTN54702843 |