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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR917 |
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Date of registration:
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20/02/2007 |
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Primary sponsor: |
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Public title:
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STOP PAIN
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Scientific title:
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Septal closure of PFO- does it prevent migraine? - STOP PAIN |
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Date of first enrolment:
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1/4/2007 |
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Target sample size:
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50 |
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Recruitment status: |
other |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=917 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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H.
Koppen |
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Address:
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Leiden University Medical Center (LUMC), Department of Neurology
Postbus 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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h.koppen@lumc.nl |
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Email:
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Affiliation:
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Name:
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H.
Koppen |
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Address:
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Leiden University Medical Center (LUMC), Department of Neurology
Postbus 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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h.koppen@lumc.nl |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Migraine, Foramen ovale persistens, Closure
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Intervention(s)
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In migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomization will be performed or sham procedure
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Primary Outcome(s)
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Number of patients experiencing 50% reduction of migraine in closure group compared with sham group.
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Secondary Outcome(s)
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Mean values of monthly migraine periods
QoL using headache impact test questionaire.
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Secondary ID(s)
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ISRCTN54702843
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Source(s) of Monetary Support
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Leiden University Medical Center (LUMC), Department of Neurology, St Jude Medical inc - Belgium
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