Pathway M-1: Sphenopalatine Ganglion Stimulation for the Treatment of Chronic or High Frequency, High Disability Migraine Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Autonomic Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01540799
First received: February 20, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Chronic Migraine
High Frequency, High Disability Migraine
Device: ATI Neurostimulation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pathway M-1: Sphenopalatine Ganglion Stimulation for the Treatment of Chronic or High Frequency, High Disability Migraine Headache

Resource links provided by NLM:


Further study details as provided by Autonomic Technologies, Inc.:

Primary Outcome Measures:
  • Major Device- and Surgical-Related Complications [ Time Frame: Implantation through completion of Experimental Period (between 14 and 22 weeks following the implantation procedure) ] [ Designated as safety issue: Yes ]
    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: Through completion of Experimental Period (between 14 and 22 weeks following the implantation procedure) ] [ Designated as safety issue: No ]

    Difference between the number of Migraine Pain Days during the last 4 weeks of the Baseline Period and the number of Migraine Pain Days during the last 4 weeks of the Experimental Period.

    Migraine Pain Day: Any day with

    1. moderate or severe headache with a duration of at least 1 hour AND meeting criteria C and D for migraine ICHD-II 1.1 OR
    2. Acute Medication (pharmacologic medications, not including SPG stimulation, used to treat migraine pain) use for a migraine attack (of any severity or duration).


Secondary Outcome Measures:
  • Headache Frequency [ Time Frame: Through completion of Experimental Period (between 14 and 22 weeks following the implantation procedure) ] [ Designated as safety issue: No ]
    Difference between the total number of Migraine Pain Days during the last 4 weeks of the Baseline Period and the total number of Migraine Pain Days including days where SPG stimulation was used for a migraine attack (of any severity or duration) during the last 4 weeks of the Experimental Period.

  • Pain Relief at 1 Hour [ Time Frame: Experimental Period (begins between 8 and 16 weeks following implantation procedure; ends between 14 and 22 weeks following implantation procedure) ] [ Designated as safety issue: No ]
    Proportion of migraine pain treatments using SPG stimulation during the Experimental Period with Pain Relief at 1 hour following the start of SPG stimulation with no Acute Medication use.

  • Pain Freedom at 1 Hour [ Time Frame: Experimental Period (begins between 8 and 16 weeks following implantation procedure; ends between 14 and 22 weeks following implantation procedure) ] [ Designated as safety issue: No ]
    Proportion of migraine pain treatments using SPG stimulation during the Experimental Period with Pain Freedom at 1 hour following the start of SPG stimulation with no Acute Medication use.

  • Migraine Associated Symptom Relief at 1 Hour [ Time Frame: Experimental Period (begins between 8 and 16 weeks following implantation procedure; ends between 14 and 22 weeks following implantation procedure) ] [ Designated as safety issue: No ]
    Proportion of migraine pain treatments using SPG stimulation during the Experimental Period with relief of migraine associated symptoms [i.e., photophobia, phonophobia, nausea/vomiting] at 1 hour following the start of SPG stimulation with no Acute Medication use.

  • Disability and Quality of Life [ Time Frame: Through Experimental Period (assessment occurs between 14 and 22 weeks following the implantation procedure) ] [ Designated as safety issue: No ]
    Disability and Quality of Life as categorized by the HIT-6, MIDAS and SF-36v2 surveys administered at the end of the Experimental Period.

  • Global Evaluation of SPG Stimulation Therapy [ Time Frame: Experimental Period (assessment occurs between 14 and 22 weeks following the implantation procedure) ] [ Designated as safety issue: No ]
    Global patient evaluation of SPG stimulation therapy (very poor, poor, no opinion, good, very good) administered at the end of the Experimental Period.

  • Prophylactic Medication Use [ Time Frame: Through Open Label Period (one year following the implantation procedure) ] [ Designated as safety issue: No ]
    Use of prophylactic medications during the Open Label Period as compared to Baseline.

  • Acute Medication Use [ Time Frame: Through Open Label Period (one year following the implantation procedure) ] [ Designated as safety issue: No ]
    Use of acute medication during the Experimental and/or Open Label Periods as compared to Baseline.


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: ATI Neurostimulation System
ATI Neurostimulator (NS-100) and Remote Controller (RC-200)
Other
Stimulation not able to be felt
Device: ATI Neurostimulation System
ATI Neurostimulator (NS-100) and Remote Controller (RC-200)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from >= 18 years old.
  • Subject has been diagnosed with migraine headache with or without aura according to the 2004 ICHD-II criteria 1.1 or 1.2.1 or chronic migraine according to 2006 ICHD-IIR Appendix 1.5.1 .
  • Subject reports at least 75% of migraine attacks having predominantly fixed (non side-shifting) unilateral temporal or ocular pain, with a preference that the subject reports associated cranial autonomic symptoms.
  • Subject reports a minimum of 8 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 in a diary for at least 1 month (4 weeks) prior to inclusion.
  • Subject reports a minimum of 4 migraine attacks per month.
  • Subject reports at least 24 hours of pain free periods between typical migraine attacks, and at least 4 migraine-free days per month.
  • Subject has a MIDAS score 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 prophylactic headache medications for at least 1 month prior to study enrollment and agrees to maintain stable type and dosage of prophylactic 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 during 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.

Exclusion Criteria:

  • Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anesthesia.
  • Subject currently has Medication Overuse Headache (MOH) according to the ICHD-IIR 2006 criteria.
  • Subject reports continuous daily headaches for one month or longer at time of consent.
  • Subject reports initial onset of migraines within the last year.
  • Subject has undergone facial surgery 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 the Neurostimulator.
  • Subject has active oral or dental abscess.
  • Subject has been treated with 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 requires 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 or 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.
  • Subject has had previous lesional radiofrequency ablation of the ipsilateral sphenopalatine ganglion (SPG).
  • Subject has had blocks or nonlesional 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 is not suitable for the study for any reason in the judgment of the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540799

Locations
Belgium
Headache Research Unit. University Department of Neurology, Citadelle Hospital Not yet recruiting
Liege, Belgium, B-4000
Contact: Pascale Gerard    +32 4 225 6391    pascale.gerard@gmail.com   
Principal Investigator: Jean Schoenen, MD, PhD         
Sub-Investigator: Delphine Magis, MD, PhD         
Denmark
Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen Recruiting
Glostrup, Copenhagen, Denmark, DK-2600
Contact: Messoud Ashina, MD, PhD, Dr.Med.Sci.    Tel: +45 4338632062      
Principal Investigator: Messoud Ashina, MD, PhD, Dr.Med.Sci.         
Spain
Servicio de Neurologia, Hospital Clinico Universitario Recruiting
Valencia, Spain, 46010
Contact: Miguel JA Lainez, MD, PhD, FAAN, CMANA    +34 963868863    neurologia_hcv@gva.es   
Principal Investigator: Jose Miguel Lainez, MD, PhD, FAAN, CMANA         
Sub-Investigator: Ana Garcia, MD         
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
Principal Investigator: Rigmor Jensen, MD, PhD Danish Headache Center, Glostrup Hospital
  More Information

No publications provided

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01540799     History of Changes
Other Study ID Numbers: Pathway M-1 (CIP-003)
Study First Received: February 20, 2012
Last Updated: May 3, 2012
Health Authority: Denmark: Danish Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Autonomic Technologies, Inc.:
Migraine
Chronic migraine
High frequency migraine
High disability migraine
Sphenopalatine ganglion
Neuromodulation
Neurostimulation
Autonomic nervous system

Additional relevant MeSH terms:
Migraine Disorders
Synovial Cyst
Ganglion Cysts
Headache
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014