Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache

NCT01540799 | Completed DMC

• 1 other identifier: Pathway M-1 (CIP-003)
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

High Frequency, High Disability Migraine

Keywords

Migraine; High disability migraine; Sphenopalatine ganglion; Neuromodulation; Neurostimulation; Autonomic nervous system

Outcome Measures

Primary Outcomes (2)

• 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

  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: 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

  During Experimental Period (12 to 18 weeks following implantation)

Other Outcomes (19)

• Number of Migraine Free Days during the Experimental Period, compared between the Treatment and Control arms.

  During Experimental Period (12 to 18 weeks following implantation)

• Number of Headache Free Days during the Experimental Period, compared between the Treatment and Control arms

  During Experimental Period (12 to 18 weeks following implantation)

• Percent change in number of Migraine Free Days during the last 4 weeks of the Experimental Period relative to the 4 weeks preceding the implantation procedure, compared between the Treatment and Control arms

  During Experimental Period (14 to 18 weeks following implantation) compared to Baseline

Study Arms (2)

Treatment

EXPERIMENTAL

Device: ATI Neurostimulation System

Other

OTHER

Stimulation not able to be felt

Device: ATI Neurostimulation System

Interventions

ATI Neurostimulation System DEVICE

ATI Neurostimulator (NS-100) and Remote Controller (RC-200)

Other; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 at least 24 hours of pain-free periods between typical migraine attacks.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Autonomic Technologies, Inc.: lead

Study Sites (3)

Dept. of Neurology, K12 Bldg. 1st fl, De Pintelaan 185 B-9000

Ghent, Belgium

Location

Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen

Glostrup Municipality, Copenhagen, DK-2600, Denmark

Location

Servicio de Neurologia, Hospital Clinico Universitario

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rigmor Jensen, MD, PhD

  Danish Headache Center, Glostrup Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2017-05

Locations

DK (1); ES (1); BE (1)