No registrations found.
ID
Source
Brief title
Health condition
PFO, migraine, closure
Foramen ovale persistens, migraine, sluiting
Sponsors and support
The corporate village 11- box F1
B-1935 Zaventem
Belgium
0032 27746937
Coordinating clinical investigators: Prof MD Ferrari, Neurology department LUMC
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Intervention
In migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomization will be performed or sham procedure
Postbus 9600
H. Koppen
Leiden 2300 RC
The Netherlands
h.koppen@lumc.nl
Postbus 9600
H. Koppen
Leiden 2300 RC
The Netherlands
h.koppen@lumc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL893 |
| NTR-old | NTR917 |
| Other | : |
| ISRCTN | ISRCTN54702843 |