Condition category
Nervous System Diseases
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
13/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pfo-lumc.nl

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

http://www.sjm.com/index.aspx

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

Publication citations

Additional files

Editorial Notes