N/A
N=140
Treatment for Migraines With an Implantable Device
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00286078 ↗Enrolled (actual)
140
Serious AEs
37.1%
Results posted
Aug 2016
Primary outcome: Primary: Migraine Frequency at 12 Weeks — -5.5; -3.9 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Precision (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Migraine Frequency at 12 Weeks |
-5.5; -3.9 | — |
| PRIMARY Frequency of Adverse Event |
276; 284 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00286078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.