MigraineNCT00369499
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
A study testing PFO Closure in people with Migraine, run by Abbott Medical Devices at 1 site in Germany.
Trial summary
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- PFO Closure
- Type of treatment
- Medical device
- How many people
- 656 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Migraine history of at least 1 year.
- Migraine patients experiencing at least 2 migraine attacks per month.
- Migraine patients experiencing at least 1 migraine attack with aura per month.
- Failure of or intolerance to at least 2 classes of prophylactic migraine medication evaluated in adequate, approved medication trials. At least one of the classes shall come from beta-blockers, anticonvulsants, calcium channel blockers and tricyclic antidepressants.
- Aged 18 - 50 years and of legal age in the host country.
- The patient or legal guardian has signed a study specific informed consent form agreeing to data collection and follow-up requirements.
- The patient agrees to abstain from starting prophylactic migraine medication or agrees to maintain existing prophylactic migraine medication without changing dose or drug from entering the baseline period throughout the duration of the study until final assessments.
- Documented right to left shunt that is suitable for device closure.
Who cannot join
- Taking migraine preventative medication for conditions other than migraine.
- History of 15 or more headache days per month.
- 8 or more non-migraine headache days per month.
- Overuse of acute headache medication (use on 10 or more days per month).
- Patient has severe central nervous system disease such as seizure disorder, inflammatory disease of the central nervous system, or a previous stroke.
- Previous surgical or device closure of a PFO or ASD.
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- Artificial heart valve.
- Pacemaker or ICD implanted within past 3 months.
- Anatomic variant that could affect successful deployment such as coronary sinus, pulmonary veins, Chiari network.
- Uncontrolled bacteremias or dental or surgical procedure within past 30 days or planned within study period.
- Allergy to contrast media, and/or to any component of the device to be used.
- Contraindicated for any medication used during or after the procedure.
- History of atrial fibrillation or atrial flutter (chronic or paroxysmal).
- Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
- Patient is undergoing dialysis for renal failure.
- Patient has NYHA class 3 or 4 cardiac failure.
- Patient is pregnant, or intends to become pregnant during the trial period.
- Patient requires anticoagulation therapy for a concomitant condition.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CardioVascular Center Frankfurt, Sankt Katharinen
Frankfurt, 60389
About this study
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.
- Conditions
- Migraine
- Being tested
- PFO Closure
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO ClosureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean values of the number of monthly migraine periods, with or without aura.
Secondary outcomes (2)
Mean values of monthly migraine frequency with or without aura.
Quality of life using a Headache Impact Test Questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startMar 2007
- Study completionJun 2009
Why it stopped: Not enough patients/ ethical concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Ferrari, Prof., Principal investigator, Leiden University Medical CentreHorst Sievert, Prof., Principal investigator, CardioVascular Center Frankfurt, Sankt Katharinen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369499
- Sponsor's protocol ID
- CV05003PC
- Status last verified
- Jun 2023
- First submitted
- 28 Aug 2006
- Last updated
- 29 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
- ClinicalTrials.gov ID
- NCT00369499
- Acronym / sponsor ID
- CV05003PC
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients/ ethical concerns
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Migraine history of at least 1 year.
- Migraine patients experiencing at least 2 migraine attacks per month.
- Migraine patients experiencing at least 1 migraine attack with aura per month.
- Failure of or intolerance to at least 2 classes of prophylactic migraine medication evaluated in adequate, approved medication trials. At least one of the classes shall come from beta-blockers, anticonvulsants, calcium channel blockers and tricyclic antidepressants.
- Aged 18 - 50 years and of legal age in the host country.
Key exclusion criteria (18 listed)
- Taking migraine preventative medication for conditions other than migraine.
- History of 15 or more headache days per month.
- 8 or more non-migraine headache days per month.
- Overuse of acute headache medication (use on 10 or more days per month).
- Patient has severe central nervous system disease such as seizure disorder, inflammatory disease of the central nervous system, or a previous stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFO Closure | Device | – |
Primary outcome
Mean values of the number of monthly migraine periods, with or without aura.
2 secondary outcomes
Mean values of monthly migraine frequency with or without aura.
Quality of life using a Headache Impact Test Questionnaire.
Results and safety
The study was stopped early (reason given: Not enough patients/ ethical concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Ferrari, Prof. principal investigator
Leiden University Medical Centre
Horst Sievert, Prof. principal investigator
CardioVascular Center Frankfurt, Sankt Katharinen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFO Closure in people with Migraine, run by Abbott Medical Devices at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patients/ ethical concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean values of the number of monthly migraine periods, with or without aura.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.