High Frequency, High Disability MigrainePathway M-1NCT01540799
Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache
A study testing ATI Neurostimulation System in people with High Frequency, High Disability Migraine, run by Autonomic Technologies, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Frequency, High Disability Migraine
- What is being tested?
- ATI Neurostimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2012to May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Subject has been diagnosed at least 3 months prior to study enrollment with migraine headache with or without aura according to the 2004 ICHD-II criteria 1.1 or 1.2.1.1.
- Subject reports at least 75% of migraine attacks having predominantly fixed (non side-shifting) unilateral temporal or ocular pain.
- Subject reports that moderate/severe migraine pain is typically preceded by a mild pain phase.
- Subject reports a minimum of 8 days per month and a maximum of 14 days per month with migraine attacks of at least moderate severity based on the subject/Investigator's knowledge for at least 3 months prior to inclusion and confirmed for at least 1 month during the Pre-Implant Baseline Period using the Pathway M-1 Daily Headache Diary.
- Subject reports at least 24 hours of pain-free periods between typical migraine attacks.
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- Subject has a MIDAS grade of III or IV, or has a HIT-6 score > 56.
- Subject is medically intractable in the opinion of the Investigator.
- Subject has had stable type and dosage of preventive headache medications for at least 1 month prior to study enrollment and agrees to maintain stable type and dosage of preventive headache medications through the completion of the Experimental Period.
- Subject is able to distinguish migraine attacks from other headaches (i.e., TTH).
- Subject agrees to not participate in supplemental or alternative therapy through the Open Label phase of the study. This includes: acupuncture, spinal manipulation, TENS, and magnetic fields treatments.
- Subject has the ability to read, comprehend, and to reliably record information as required by the Protocol.
- Subject is able to provide written informed consent prior to participation in the study.
Who cannot join
- Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anesthesia.
- Subject has been diagnosed with chronic migraine during the last year according to 2006 ICHD-IIR Appendix 1.5.1.
- Subject currently has Medication Overuse Headache (MOH) or has a history of MOH during the last year according to the ICHD-2R 2006 criteria.
- Subject has used any triptans, pain medications or analgesics of any kind for any indication on more than 14 days per month over the last three months.
- Subject reports continuous daily headaches for one month or longer at time of consent.
- Subject reports initial onset of migraines within the last year.
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- Subject has undergone facial surgery or has metallic implants in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site that, in the opinion of the Investigator, may lead to the inability to properly implant or use the Neurostimulator.
- Subject has active oral or dental abscess.
- Subject has been treated with therapeutic radiation to the facial region.
- Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past 6 months or require periodic MRI follow-up.
- Subject's pterygomaxillary fissure is less than 1.2 mm in width at the level of the vidian canal, as determined by CT scan.
- Subject has clinically significant drug (including opioid) or alcohol abuse as defined by DSM-IV-TR, will likely be unable to refrain from substance abuse throughout the study, has other significant pain problem, substance abuse or active depressive episode that might confound the study assessments in the opinion of the Investigator.
- Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to an investigational drug or device.
- Subject is felt to be at risk of non-compliance (e.g., for completing the diary, maintaining a stable headache medicine regimen or returning for required follow-up visits) in the Investigator's opinion.
- Subject is a woman of childbearing age who is pregnant, nursing, or not using contraception. A sterilized or infertile woman is exempt from the requirement to use contraception.
- Subject has had previous lesional radiofrequency ablation of the ipsilateral sphenopalatine ganglion (SPG).
- Subject has had blocks or non-lesional pulsed RF of the ipsilateral SPG in the last 3 months.
- Subject has undergone botulinium toxin injections of the head and/or neck in the last 3 months.
- Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
- Subject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication in preparation for the implantation procedure.
- Subject has a chronic neurological illness of the face (e.g., facial nerve paralysis, trigeminal neuralgia).
- Subject is not suitable for the study for any reason in the judgment of the Investigator.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site
Dept. of Neurology, K12 Bldg. 1st fl, De Pintelaan 185 B-9000
Ghent
Denmark1 site
Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
Glostrup Municipality, Copenhagen, DK-2600
Spain1 site
Servicio de Neurologia, Hospital Clinico Universitario
Valencia, 46010
About this study
The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.
- Conditions
- High Frequency, High Disability Migraine
- Being tested
- ATI Neurostimulation System
- Keywords
- Migraine, High disability migraine, Sphenopalatine ganglion, Neuromodulation, Neurostimulation, Autonomic nervous system
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI Neurostimulation SystemDevice
ATI Neurostimulator (NS-100) and Remote Controller (RC-200)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: ATI Neurostimulation System |
| Other | Other | Stimulation not able to be felt Receives: Device: ATI Neurostimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Device- and Surgical-Related Complications
Occurrence rate of death, any surgery or hospitalization due to deterioration in subject health, or other Major Device-related Adverse Events
Measured: Implantation through completion of Experimental Period (18 weeks following the implantation procedure)
Effective Therapy
Number of Migraine Pain Days during the Experimental Period, compared between the Treatment and Control arms.
Migraine Pain Day is any calendar day that:
- Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND
- No Acute Headache or Migraine Pain Medication (pharmacologic medications, not including SPG stimulation, used to treat acute headache pain). AND
- No SPG stimulation is applied for headache pain of any intensity
Measured: During Experimental Period (12 to 18 weeks following implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Frequency, High Disability 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autonomic Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rigmor Jensen, MD, PhD, Principal investigator, Danish Headache Center, Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540799
- Sponsor's protocol ID
- Pathway M-1 (CIP-003)
- Acronym
- Pathway M-1
- Status last verified
- May 2017
- First submitted
- 20 Feb 2012
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache
- ClinicalTrials.gov ID
- NCT01540799
- Acronym / sponsor ID
- Pathway M-1 / Pathway M-1 (CIP-003)
- Conditions
- High Frequency, High Disability Migraine
- Keywords
- Migraine, High disability migraine, Sphenopalatine ganglion, Neuromodulation, Neurostimulation, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Autonomic Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Feb 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.
The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: ATI Neurostimulation System |
| Other | Other | Device: ATI Neurostimulation SystemStimulation not able to be felt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years old.
- Subject has been diagnosed at least 3 months prior to study enrollment with migraine headache with or without aura according to the 2004 ICHD-II criteria 1.1 or 1.2.1.1.
- Subject reports at least 75% of migraine attacks having predominantly fixed (non side-shifting) unilateral temporal or ocular pain.
- Subject reports that moderate/severe migraine pain is typically preceded by a mild pain phase.
- Subject reports a minimum of 8 days per month and a maximum of 14 days per month with migraine attacks of at least moderate severity based on the subject/Investigator's knowledge for at least 3 months prior to inclusion and confirmed for at least 1 month during the Pre-Implant Baseline Period using the Pathway M-1 Daily Headache Diary.
Key exclusion criteria (22 listed)
- Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anesthesia.
- Subject has been diagnosed with chronic migraine during the last year according to 2006 ICHD-IIR Appendix 1.5.1.
- Subject currently has Medication Overuse Headache (MOH) or has a history of MOH during the last year according to the ICHD-2R 2006 criteria.
- Subject has used any triptans, pain medications or analgesics of any kind for any indication on more than 14 days per month over the last three months.
- Subject reports continuous daily headaches for one month or longer at time of consent.
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 |
|---|---|---|
| ATI Neurostimulation SystemATI Neurostimulator (NS-100) and Remote Controller (RC-200) | Device | Other, Treatment |
Primary outcome
Major Device- and Surgical-Related Complications
Time frame: Implantation through completion of Experimental Period (18 weeks following the implantation procedure)
Occurrence rate of death, any surgery or hospitalization due to deterioration in subject health, or other Major Device-related Adverse Events
Effective Therapy
Time frame: During Experimental Period (12 to 18 weeks following implantation)
Number of Migraine Pain Days during the Experimental Period, compared between the Treatment and Control arms. Migraine Pain Day is any calendar day that: 1. Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND 2. No Acute Headache or Migraine Pain Medication (pharmacologic medications, not including SPG stimulation, used to treat acute headache pain). AND 3. No SPG stimulation is applied for headache pain of any intensity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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.
Rigmor Jensen, MD, PhD principal investigator
Danish Headache Center, Glostrup Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATI Neurostimulation System in people with High Frequency, High Disability Migraine, run by Autonomic Technologies, Inc. at 3 sites in 3 countries.
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 22 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: finished, as of the sponsor's last update on 26 Jun 2018. 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 Belgium, Denmark, Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major Device- and Surgical-Related Complications (time frame: Implantation through completion of Experimental Period (18 weeks following the implantation procedure)). 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 26 Jun 2018.