Acute MigraineNCT01680029
PBASE-system Acute Migraine Clinical Investigation
A study testing PBASE-system 2.0 in people with Acute Migraine, run by Chordate Medical at 3 sites in United Kingdom.
Trial summary
To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Migraine
- What is being tested?
- PBASE-system 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2013to not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to participation in the clinical investigation
- Male or female aged between 18 and 65 years
- Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II)
- Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month
- Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month
- Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month
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- Reported history of the majority of untreated migraine attack durations lasting 8 hours or more
- Onset of migraine headache occured before age 50
- Reported history of migraine for more than one year
- Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment
- Able to understand and complete the electronic diary
- Experiencing an acute migraine attack of moderate to severe pain intensity at the time of treatment
- Treatment is possible within 5 hours of migraine onset
Who cannot join
- Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month
- Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month
- Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack
- Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit
- Previously treated with an implantable stimulator or any implantable devices in the head and/or neck
- Diagnosed as having a pronounced anterior septal deviation
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- History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea
- Fitted with a pacemaker /defibrillator
- Previously treated with radiation to the face
- Ongoing bacterial infection in the nasal cavity
- History of nose bleeds (epistaxis)
- Ongoing malignancy in the nasal cavity
- Concomitant condition that could cause excessive bleeding
- Known allergy to polyvinylchloride,the material used for fabrication of the balloon part of Catheter A100, or medicinal liquid paraffin
- Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation
- Any change in migraine prophylaxis between the screening and treatment visit
- Women of childbearing potential who is pregnant or at risk of becoming pregnant prior to or during the treatment phase
- Participation in a clinical research study within 3 months of enrolment or planned participation at any time during this clinical investigation
- Considered to meet the definition of vulnerable in the Investigator's opinion
- Headache or migraine episode within the 48 hours prior to treatment
- PRN (as required) or acute migraine medication(s) taken within the 48 hours prior to treatment
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Study site
Glasgow
Study site
London
Study site
Stoke-on-Trent
About this study
Official title: A Clinical Investigation to Evaluate the Safety and Performance of the PBASE-system When Used in the Treatment of Acute Migraine Episodes of Moderate to Severe Intensity
To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect.
- Conditions
- Acute Migraine
- Being tested
- PBASE-system 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBASE-system 2.0Device
| Study group | Role | What they receive |
|---|---|---|
| PBASE-system 2.0 | Experimental | Not described Receives: Device: PBASE-system 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache relief
Measured: 2 hours post-initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJan 2013
Why it stopped: Too slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chordate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680029
- Sponsor's protocol ID
- PM001
- Status last verified
- Nov 2013
- First submitted
- 3 Sep 2012
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Evaluate the Safety and Performance of the PBASE-system When Used in the Treatment of Acute Migraine Episodes of Moderate to Severe Intensity
- ClinicalTrials.gov ID
- NCT01680029
- Acronym / sponsor ID
- PM001
- Conditions
- Acute Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruitment rate
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chordate MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- First posted
- 6 Sep 2012 (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.
To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBASE-system 2.0 | Experimental | Device: PBASE-system 2.0 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent prior to participation in the clinical investigation
- Male or female aged between 18 and 65 years
- Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II)
- Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month
- Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month
Key exclusion criteria (21 listed)
- Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month
- Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month
- Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack
- Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit
- Previously treated with an implantable stimulator or any implantable devices in the head and/or neck
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 |
|---|---|---|
| PBASE-system 2.0 | Device | PBASE-system 2.0 |
Primary outcome
Headache relief
Time frame: 2 hours post-initiation of treatment
Results and safety
The study was stopped early (reason given: Too slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBASE-system 2.0 in people with Acute Migraine, run by Chordate Medical at 3 sites in United Kingdom.
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 13 inclusion and 21 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 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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: Too slow recruitment rate). 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?
Headache relief (time frame: 2 hours post-initiation of treatment). 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 11 Nov 2013.