Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Occipital Nerve Stimulation for Drug Refractory Migraine (PRISM UK)

This study has been terminated.
(Sponsor closed enrollment early based on interim data from the PRISM US Pivotal Study.)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00747812
First received: September 4, 2008
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Migraine
Device: Precision
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Number of Hours of Headache [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of Days With 4 or More Hours of Headache [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2006
Study Completion Date: May 2012
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Precision
Implantable Neurostimulator
Sham Comparator: 2
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
Device: Precision
Implantable Neurostimulator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747812

Locations
United Kingdom
Royal Free Hospital - Dept of Clinical Neurosciences
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Peter J. Goadsby, MD Royal Free Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00747812     History of Changes
Other Study ID Numbers: PRISM-UK-05
Study First Received: September 4, 2008
Results First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:
Headache
Migraine
Refractory
Chronic
Pain

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014