Septal closure of patent foramen ovale: does it prevent migraine?

ISRCTN	ISRCTN54702843
DOI	https://doi.org/10.1186/ISRCTN54702843
ClinicalTrials.gov number	NCT00369499
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr H Koppen
Scientific

Leiden University Medical Centre (LUMC)
Department of Neurology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Email	h.koppen@lumc.nl

Study design	Randomised, placebo controlled, parallel group, double blind, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Septal closure of patent foramen ovale: does it prevent migraine?
Study acronym	STOP PAIN
Study objectives	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.
Ethics approval(s)	Approval pending from the LUMC ethics committee.
Health condition(s) or problem(s) studied	Migraine, foramen ovale persistens, closure
Intervention	In migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomisation will be performed, versus a sham procedure.
Intervention type	Other
Primary outcome measure	Number of patients experiencing 50% reduction of migraine in closure group compared with sham group. Outcomes will be measured monthly from three to nine months after closure.
Secondary outcome measures	1. Mean values of monthly migraine periods 2. Quality of Life (QoL) using headache impact test questionaire Outcomes will be measured monthly from three to nine months after closure.
Overall study start date	01/04/2007
Completion date	01/04/2008
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	50
Key inclusion criteria	1. Migraine with aura 2. Migraine history of at least one year: a. at least two migraine attacks/month b. at least one migraine attack with aura 3. Failure or intolerance to two classes prophylactic migraine medication 4. Aged 18 to 50 years 5. Right to left shunt suitable for closure
Key exclusion criteria	1. History of 15 or more headache days per month 2. Taking preventive medication for other conditions other than migraine 3. Eight or more non-migraine headache days/month 4. Overuse of acute headache medication (use on ten or more days/month) 5. Severe central nervous system disease 6. Previous surgical or device closure of Patent Foramen Ovale (PFO)/Atrial Septal Defect (ASD) 7. Atrial heart valve 8. Pacemaker or Implantable Cardioverter Defibrillator (ICD) implanted within past three months 9. History of atrial fibrillation 10. Undergoing dialysis 11. New York Heart Association (NYHA) class three or four cardiac failure 12. Pregnant 13. Anticoagulation
Date of first enrolment	01/04/2007
Date of final enrolment	01/04/2008

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

St Jude Medical Inc (Belgium)
Industry

The Corporate Village
Da Vincilaan 11 - Box F1
Zaventem
B-1935
Belgium

Website	http://www.sjm.com/index.aspx
"ROR"	https://ror.org/04x0p4p48

Industry

St Jude Medical Inc (Belgium)

No information available

Leiden University Medical Centre (LUMC) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

01/02/2019: Clinicaltrials.gov states that this trial was terminated by February 2008 due to low accrual/ethical concerns