MigrainePhase 2/3NCT00283738
MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant
A Phase 2/3 study testing BioSTAR Septal Repair Implant System in people with Migraine and Aura, run by NMT Medical at 2 sites in United States.
Trial summary
The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed medications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Aura, Patent Foramen Ovale
- What is being tested?
- BioSTAR Septal Repair Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 610 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Mar 2008
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 60.
- migraine history prior to age 50
- must meet definition of refractory migraine with aura
- must have a Patent Foramen Ovale (PFO) within bubble study specifications.
- must provide informed consent. Guardian consent is not accepted.
- patient's heart structure and vasculature must be compatible with BioSTAR Septal Repair Implant System.
- patient must not be pregnant and agrees not to become pregnant during study participation
Who cannot join
- Medical conditions or medications that are not compatible with protocol or that would increase the patient's risk.
- patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for PFO occlusion.
- Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Swedish Medical Center
Seattle, Washington, 98104
New England Center for Headache
Stamford, Connecticut, 06902
About this study
Official title: A Prospective, Multi-Center, Double-Blinded, Placebo-Controlled Trial to Evaluate the Effectiveness of Patent Foramen Ovale Closure With the BioSTAR Septal Repair Implant to Reduce Refractory Migraine Headache With Aura.
The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed medications.
Read the detailed description
During the last five years, transcatheter and surgical closure of PFO in the cyrptogenic stroke and TIA population has grown in frequency world-wide. Observational retrospective reports, from both single and multi-center experiences of over 400 patients, suggest Patent Foramen Ovale (PFO) closure to reduce the risk of recurrent migraine events in these populations may be beneficial, particularly for those patients in the migraine with aura subgroup. Although none of these reports are from prospective, randomized, controlled trials, the reports are compelling enough in their totality to support further investigation of a well defined group in a prospective manner. The patients reported in these studies were brought to PFO closure with no expectation of their procedure having any impact on their migraine. In fact, in many cases, the discovery of a history of migraine was not made until well after the PFO closure procedure.
This clinical trial will prospectively compare the safety and effectiveness of PFO closure with the BioSTAR device to a control arm. Patients will be followed one year post-implant.
- Conditions
- Migraine, Aura, Patent Foramen Ovale
- Being tested
- BioSTAR Septal Repair Implant System, Sham Procedure
- Keywords
- migraine, aura, Patent Foramen Ovale (PFO), cardiac defects, Heart Septal Defects, Atrial, Cephalalgia
- Medical subject headings
- Migraine Disorders, Epilepsy, Foramen Ovale, Patent, Heart Septal Defects, Atrial, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioSTAR Septal Repair Implant SystemDevice
PFO Closure
Sham ProcedureProcedure or surgery
Catheterization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: BioSTAR Septal Repair Implant System |
| 2 | Placebo comparator | Sham control Receives: Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Migraine reduction rates during analysis period.
Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
Secondary outcomes (3)
Efficacy:Change in number of attacks from baseline period compared to analysis phase.
Safety: Device success during index procedure without procedural complication.
Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionMar 2008 (estimated)
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NMT Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Reisman, MD, Principal investigator, Swedish Medical Center, Seattle, WAStewart J. Tepper, MD, Principal investigator, Director of the New England Center for Headache
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283738
- Sponsor's protocol ID
- G050119
- Other IDs
- MIST II
- Status last verified
- Jan 2008
- First submitted
- 27 Jan 2006
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Double-Blinded, Placebo-Controlled Trial to Evaluate the Effectiveness of Patent Foramen Ovale Closure With the BioSTAR Septal Repair Implant to Reduce Refractory Migraine Headache With Aura.
- ClinicalTrials.gov ID
- NCT00283738
- Acronym / sponsor ID
- G050119
- Conditions
- Migraine, Aura, Patent Foramen Ovale
- Keywords
- migraine, aura, Patent Foramen Ovale (PFO), cardiac defects, Heart Septal Defects, Atrial, Cephalalgia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- NMT MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Mar 2008 (estimated)
- First posted
- 30 Jan 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 objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed medications.
Detailed description
During the last five years, transcatheter and surgical closure of PFO in the cyrptogenic stroke and TIA population has grown in frequency world-wide. Observational retrospective reports, from both single and multi-center experiences of over 400 patients, suggest Patent Foramen Ovale (PFO) closure to reduce the risk of recurrent migraine events in these populations may be beneficial, particularly for those patients in the migraine with aura subgroup. Although none of these reports are from prospective, randomized, controlled trials, the reports are compelling enough in their totality to support further investigation of a well defined group in a prospective manner. The patients reported in these studies were brought to PFO closure with no expectation of their procedure having any impact on their migraine. In fact, in many cases, the discovery of a history of migraine was not made until well after the PFO closure procedure.
This clinical trial will prospectively compare the safety and effectiveness of PFO closure with the BioSTAR device to a control arm. Patients will be followed one year post-implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: BioSTAR Septal Repair Implant System |
| 2 | Placebo comparator | Procedure: Sham ProcedureSham control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age between 18 and 60.
- migraine history prior to age 50
- must meet definition of refractory migraine with aura
- must have a Patent Foramen Ovale (PFO) within bubble study specifications.
- must provide informed consent. Guardian consent is not accepted.
Key exclusion criteria (3 listed)
- Medical conditions or medications that are not compatible with protocol or that would increase the patient's risk.
- patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for PFO occlusion.
- Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.
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 |
|---|---|---|
| BioSTAR Septal Repair Implant SystemPFO Closure | Device | 1 |
| Sham ProcedureCatheterization | Procedure or surgery | 2 |
Primary outcome
Efficacy: Migraine reduction rates during analysis period.
Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
3 secondary outcomes
Efficacy:Change in number of attacks from baseline period compared to analysis phase.
Safety: Device success during index procedure without procedural complication.
Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
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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.
Mark Reisman, MD principal investigator
Swedish Medical Center, Seattle, WA
Stewart J. Tepper, MD principal investigator
Director of the New England Center for Headache
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BioSTAR Septal Repair Implant System in people with Migraine and Aura, run by NMT Medical at 2 sites in United States.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Efficacy: Migraine reduction rates during analysis period.. The study lists 2 primary outcomes in all. 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 25 Jan 2008.