NCT00747812
Terminated
Phase 2
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine
ConditionsMigraine
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Number of Hours of Headache
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.
Investigators
Eligibility Criteria
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 fo 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.
Exclusion Criteria
- •Have onset of headache after age 50;
- •Are current substance abusers (including alcohol and illicit drugs);
- •Have a significant psychiatric disorder;
- •Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
- •Have had nerve stimulation for pain relief.
- •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 radiofrequency procedure currently in effect.
- •Have a condition currently requiring or likely to require the use of MRI or diathermy;
- •Have an active implantable device;
- •Are pregnant or lactating or planning to become pregnant in the next 14 months;
Outcomes
Primary Outcomes
Number of Hours of Headache
Time Frame: 12 weeks
Number of Days With 4 or More Hours of Headache
Time Frame: 12 Weeks
Study Sites (1)
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