Back to resultsStudy of Occipital Nerve Stimulation for Drug Refractory Migraine (PRISM UK)
Primary Purpose
Migraine
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Precision
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Headache, Migraine, Refractory, Chronic, Pain
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;
- 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.
Sites / Locations
- Royal Free Hospital - Dept of Clinical Neurosciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
Outcomes
Primary Outcome Measures
Number of Hours of Headache
Number of Days With 4 or More Hours of Headache
Secondary Outcome Measures
Full Information
NCT ID
NCT00747812
First Posted
September 4, 2008
Last Updated
November 12, 2020
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00747812
Brief Title
Study of Occipital Nerve Stimulation for Drug Refractory Migraine
Acronym
PRISM UK
Official Title
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor closed enrollment early based on interim data from the PRISM US Pivotal Study.
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Headache, Migraine, Refractory, Chronic, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
Intervention Type
Device
Intervention Name(s)
Precision
Intervention Description
Implantable Neurostimulator
Primary Outcome Measure Information:
Title
Number of Hours of Headache
Time Frame
12 weeks
Title
Number of Days With 4 or More Hours of Headache
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Goadsby, MD
Organizational Affiliation
Royal Free Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free Hospital - Dept of Clinical Neurosciences
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Occipital Nerve Stimulation for Drug Refractory Migraine
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