Contact information
Type
Scientific
Primary contact
Dr H Koppen
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
Department of Neurology
P.O. Box 9600
Leiden
2300 RC
Netherlands
h.koppen@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00369499
Protocol/serial number
N/A
Study information
Scientific title
Acronym
STOP PAIN
Study 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.
Ethics approval
Approval pending from the LUMC ethics committee.
Study design
Randomised, placebo controlled, parallel group, double blind, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2007
Overall trial end date
01/04/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
50
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
01/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
St Jude Medical Inc (Belgium)
Sponsor details
The Corporate Village
Da Vincilaan 11 - Box F1
Zaventem
B-1935
Belgium
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
St Jude Medical Inc (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Leiden University Medical Centre (LUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary