Migraine
Conditions
Keywords
Headache, Migraine, Refractory, Chronic, Pain
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.
Interventions
DEVICEPrecision
Implantable neurostimulator
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Be diagnosed with multiple migraines per month of moderate to severe intensity; * Be refractory to medication; * Be an appropriate candidate for the surgical procedures required for this study; * Be willing and able to comply with all study related procedures; * Be capable of reading and understanding patient information materials and giving written informed consent. Key
Exclusion criteria
* Have onset of migraine after age 50; * Have a significant psychiatric disorder; * Have previously been treated with occipital nerve stimulation; * Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment; * Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect; * Have a condition currently requiring or likely to require the use of MRI or diathermy; * Have an active implantable device; * Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Frequency at 12 Weeks | Baseline and 12 weeks | Change from baseline in migraine days/month at 12 weeks |
| Frequency of Adverse Event | 26 weeks | Cumulative frequency of adverse events from randomization to 26 weeks |
Countries
United States
Participant flow
Pre-assignment details
179 subjects signed consent, 39 subjects screen failed, and 140 eligible subjects were randomized (1 subject was later excluded).
Participants by arm
| Arm | Count |
|---|---|
| Treatment Stimulation on
Precision: Implantable neurostimulator | 71 |
| Control Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator | 68 |
| Total | 139 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 11.2 | 43.8 years STANDARD_DEVIATION 11.9 | 42.6 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 71 participants | 68 participants | 139 participants |
| Sex: Female, Male Female | 60 Participants | 57 Participants | 117 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 68 / 72 | 63 / 68 |
| serious Total, serious adverse events | 33 / 72 | 19 / 68 |
Outcome results
Primary
Frequency of Adverse Event
Cumulative frequency of adverse events from randomization to 26 weeks
Time frame: 26 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Frequency of Adverse Event | 276 events |
| Control | Frequency of Adverse Event | 284 events |
Primary
Migraine Frequency at 12 Weeks
Change from baseline in migraine days/month at 12 weeks
Time frame: Baseline and 12 weeks
Population: Modified Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Migraine Frequency at 12 Weeks | -5.5 days | Standard Deviation 8.7 |
| Control | Migraine Frequency at 12 Weeks | -3.9 days | Standard Deviation 8.2 |