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Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168764
Recruitment Status : Active, not recruiting
First Posted : June 20, 2014
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • Primary Safety [ Time Frame: One year post-implant ]
    Characterization of all serious adverse events in all subjects who undergo an implantation procedure, through the completion of the Open Label Period.
  • Primary Efficacy [ Time Frame: 28 weeks post-implant ]
    Compared between the two study arms: Proportion of stimulation-treated ipsilateral cluster attacks that achieve pain relief at 15 minutes following the start of stimulation without the use of acute medications prior to that time point.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02168764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Secondary Efficacy [ Time Frame: 28 weeks post-implant ]
Compared between the two study arms: Proportion of stimulation-treated ipsilateral cluster attacks that achieve pain freedom at 15 minutes following the start of stimulation without the use of acute medications prior to that time point.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
Official Title  ICMJE Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
Brief Summary The primary objective of the study is to demonstrate the safety and efficacy of SPG stimulation with the ATI Neurostimulation System when used to treat acute cluster attacks in chronic cluster headache patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Cluster Headache
Intervention  ICMJE Device: ATI Neurostimulation System
All subjects will be implanted with the ATI Neurostimulator which, along with the ATI Remote Controller, provides electrical stimulation.
Study Arms  ICMJE
  • Experimental: Treatment
    Both arms of the study receive the ATI Neurostimulation System. Subjects are implanted with the ATI Neurostimulator and instructed to use the ATI Remote Controller to treat cluster attacks of at least moderate intensity by stimulating for 15 minutes before using any acute medications.
    Intervention: Device: ATI Neurostimulation System
  • Active Comparator: Control
    Both arms of the study receive the ATI Neurostimulation System. Subjects are implanted with the ATI Neurostimulator and instructed to use the ATI Remote Controller to treat cluster attacks of at least moderate intensity by stimulating for 15 minutes before using any acute medications.
    Intervention: Device: ATI Neurostimulation System
Publications * Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age from ≥22 years old.
  • Subject has been diagnosed with chronic cluster headache according to the 2013 ICHD, 3rd edition (beta version), criterion 3.1.2.
  • Subject reports a minimum of 4 cluster attacks per week on the side of their dominant headache laterality. Subjects who report more than 8 attacks per day or attack duration of less than 30 minutes (untreated or unsuccessfully treated) must have been tested to rule out other forms of trigeminal autonomic cephalalgias.
  • Both subject and physician judge previously or currently used preventive and/or acute cluster headache treatment to be inadequate.
  • Subject is able to distinguish cluster attacks from other headaches (i.e., migraine, tension-type headaches).
  • Subject agrees to not use therapy involving TENS or magnetic field treatment while the Neurostimulator is implanted.
  • Subject agrees to not participate in supplemental or alternative therapy, including acupuncture and spinal manipulation, from Study Enrollment through the end of the Experimental Period of the study.
  • Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) - except to manage tolerability - from Study Enrollment through the Experimental Period of the study.
  • Subject agrees not to use any acute medications, including oxygen therapy, for their treatable cluster attacks during the Experimental Period until after they have used SPG stimulation therapy for at least 15 minutes.
  • Subject has had a dental examination and cleaning in the past six (6) months.
  • Subject has the ability to read and 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 has had a change in type, dosage or dose frequency of preventive headache medications < one (1) month prior to study enrollment
  • Subject has been diagnosed with any other form of Trigeminal Autonomic Cephalalgias (e.g., paroxysmal hemicrania, SUNCT, etc.) or has a history of trigeminal neuralgia.
  • 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 an inability to properly implant the Neurostimulator.
  • Subject currently has an active oral or dental abscess or an active maxillary sinus infection based on present symptoms.
  • 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 six (6) months.
  • Subject has other significant pain problem(s) that, in the opinion of the Investigator, might confound the study assessments.
  • Subject is a woman of childbearing potential who is pregnant, nursing, or not using contraception.
  • 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 or non-investigational drug or device.
  • Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or maintaining a stable headache medicine regimen or returning for required follow-up visits).
  • Subject is at risk of being unable to complete at least 1 year of follow-up (e.g., has plans to relocate).
  • Subject has had previous lesional radio-frequency (RF) ablation, balloon compression, gamma knife, or glycerol treatments of the ipsilateral sphenopalatine ganglion (SPG), trigeminal ganglion or any branch of the trigeminal nerve.
  • Subject has had blocks or non-lesional pulsed RF of the ipsilateral SPG in the last three (3) months.
  • 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 undergone onabotulinumtoxinA injections of the head and/or neck or has had an occipital nerve block in the last three (3) months.
  • Subject has or requires an active implanted medical device, such as a pacemaker/defibrillator, other neurostimulator, or cochlear implant.
  • Subject is expected to require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS).
  • Subject has a history of bleeding disorders or coagulopathy and is unable to discontinue anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication in preparation for the implantation procedure.
  • In the opinion of the Investigator, the subject currently meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for an active major depressive episode or for active significant psychiatric disorders, including dementia, uncontrolled general anxiety disorder, psychotic disorders or uncontrolled bipolar disorder. Exclusion criteria also include: active psychosis, untreated severe anxiety disorder, homicidal ideation, significant Axis II disorders and significant untreated sleep disorders.
  • Subject currently has clinically significant drug or alcohol abuse as defined by DSM-IV-TR or is unable to refrain from substance abuse throughout the study.
  • Subject has a history of malignancy or any other condition that requires MRI monitoring.
  • Subject has a history of allergic or hypersensitive reactions to titanium, platinum, or implant grade silicone-polyurethane copolymers.
  • Subject may be, in the opinion of the Investigator, at greater risk of infection (e.g., subjects with diabetes, taking steroids, with gingivitis/periodontitis, malnutrition or anorexia/bulimia) or at higher risk of harm from infections.
  • Subject is currently using a tobacco cessation regimen (e.g. Wellbutrin, Zyban, Aplenzin, etc.).
  • Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168764
Other Study ID Numbers  ICMJE Pathway CH-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Autonomic Technologies, Inc.
Study Sponsor  ICMJE Autonomic Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter J Goadsby, MD, PhD UCSF Medical Center, Headache Center
Principal Investigator: David W Dodick, MD Mayo Clinic, Department of Neurology
PRS Account Autonomic Technologies, Inc.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP