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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00747812
Other study ID # PRISM-UK-05
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2006
Est. completion date May 2012

Study information

Verified date November 2020
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date May 2012
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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; - Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Precision
Implantable Neurostimulator

Locations

Country Name City State
United Kingdom Royal Free Hospital - Dept of Clinical Neurosciences London

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Hours of Headache 12 weeks
Primary Number of Days With 4 or More Hours of Headache 12 Weeks
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