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.
Brief Title
Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine Disorders
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
headache
pain
chronic
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
21 Years
NCT Id
NCT01775735
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
G120051
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
Primary Outcomes
Outcome Description
A moderate-to-severe headache day will be defined as any calendar day with:
1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity
OR
2. 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.
1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity
OR
2. 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.
Outcome Measure
Change in the Number of Moderate-to-severe Headache Days Per Month
Outcome Time Frame
from Baseline to 6 months post-randomization
Secondary Ids
Secondary Id
CDM00046436
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Richard Lipton
Investigator Email
richard.lipton@einsteinmed.org
Investigator Phone