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Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE (OPTIMISE)

Primary Purpose

Migraine Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occipital nerve stimulator
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring headache, pain, chronic

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
  • Evidence of intractability
  • Posterior-dominant head pain
  • Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
  • Onset of migraine before the age of 50
  • If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test

Key Exclusion Criteria:

  • Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
  • Untreated panic disorder
  • Untreated major depression evidenced by a PHQ-9 score >20
  • Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
  • Currently diagnosed with severe personality disorder
  • A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception
  • Participating in another drug, device, or biologics trial within 3 months prior to Screening
  • A terminal illness associated with survival <24 months

Sites / Locations

  • Boston Scientific Clinical Research Information Toll Free Number
  • University of Illinois at Chicago (Implanting Physician)
  • Diamond Headache Clinic (Headache Physician)
  • Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
  • Henry Ford Hospital (Headache Physician)
  • Henry Ford Medical Group (Implanting Physician)
  • Mercy Pain Management -Surgery Center (Implanting Physician)
  • Clinvest Research, LLC (Headache Physician)
  • Montefiore Headache Center (Headache Physician)
  • NYU Medical Center (Implanting Physician)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization

The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization

Outcomes

Primary Outcome Measures

Change in the Number of Moderate-to-severe Headache Days Per Month
A moderate-to-severe headache day will be defined as any calendar day with: headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR a subject taking a triptan or ergot, regardless of headache pain duration or severity The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2013
Last Updated
November 10, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01775735
Brief Title
Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
Acronym
OPTIMISE
Official Title
Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
April 10, 2013 (Actual)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
January 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.
Detailed Description
Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
headache, pain, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Intervention Type
Device
Intervention Name(s)
Occipital nerve stimulator
Other Intervention Name(s)
Boston Scientific Precision System
Intervention Description
Electrical stimulation of the greater occipital nerve
Primary Outcome Measure Information:
Title
Change in the Number of Moderate-to-severe Headache Days Per Month
Description
A moderate-to-severe headache day will be defined as any calendar day with: headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR a subject taking a triptan or ergot, regardless of headache pain duration or severity The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.
Time Frame
from Baseline to 6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history Evidence of intractability Posterior-dominant head pain Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening Onset of migraine before the age of 50 If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test Key Exclusion Criteria: Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia) Untreated panic disorder Untreated major depression evidenced by a PHQ-9 score >20 Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15 Currently diagnosed with severe personality disorder A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception Participating in another drug, device, or biologics trial within 3 months prior to Screening A terminal illness associated with survival <24 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lipton, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Scientific Clinical Research Information Toll Free Number
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
University of Illinois at Chicago (Implanting Physician)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Diamond Headache Clinic (Headache Physician)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Henry Ford Hospital (Headache Physician)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford Medical Group (Implanting Physician)
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Mercy Pain Management -Surgery Center (Implanting Physician)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Clinvest Research, LLC (Headache Physician)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Montefiore Headache Center (Headache Physician)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
NYU Medical Center (Implanting Physician)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

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