- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00747812
Study of Occipital Nerve Stimulation for Drug Refractory Migraine (PRISM UK)
November 12, 2020 updated by: Boston Scientific Corporation
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, NW3 2QG
- Royal Free Hospital - Dept of Clinical Neurosciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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.
|
Implantable Neurostimulator
|
Sham Comparator: 2
Sham Stimulation from activation of device to 12 weeks post-activation.
Stimulation on from 12 weeks post-activation on.
|
Implantable Neurostimulator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Hours of Headache
Time Frame: 12 weeks
|
12 weeks
|
Number of Days With 4 or More Hours of Headache
Time Frame: 12 Weeks
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter J. Goadsby, MD, Royal Free Hospital NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
September 4, 2008
First Submitted That Met QC Criteria
September 4, 2008
First Posted (Estimate)
September 5, 2008
Study Record Updates
Last Update Posted (Actual)
November 27, 2020
Last Update Submitted That Met QC Criteria
November 12, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRISM-UK-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
Fundación de Investigación Biomédica - Hospital...Hospital Universitario La Fe; Hospital Vall d'Hebron; Hospital Universitario... and other collaboratorsRecruitingMigraine | Migraine Disorders | Migraine Headache | Migraine Without Aura | Migraine With AuraSpain
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
Clinical Trials on Precision
-
Boston Scientific CorporationCompletedPain | Back Pain | Chronic Pain | Pain, Intractable | Failed Back Surgery SyndromeUnited States
-
Boston Scientific CorporationCompleted
-
Boston Scientific CorporationCompleted
-
Boston Scientific CorporationTerminatedPain | Peripheral Neuropathy | Diabetic NeuropathyUnited States
-
Boston Scientific CorporationTerminatedPain | Chronic Pain | Intractable PainUnited States
-
Boston Scientific CorporationCompletedPain | Neuropathic PainUnited States
-
Boston Scientific CorporationTerminatedBack Pain | Chronic Pain | Pain in Leg, UnspecifiedUnited States
-
Bellus Medical, LLCCompletedWrinklesUnited States
-
National Yang Ming UniversityFar Eastern Memorial Hospital; National Science and Technology CouncilNot yet recruitingMild Cognitive Impairment
-
Boston Scientific CorporationCompletedChronic PainUnited States