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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

September 4, 2008
June 28, 2012
May 2006
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Migraine frequency and severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Frequency of Adverse Events [ Time Frame: Throughout the Study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00747812 on ClinicalTrials.gov Archive Site
Not Provided
  • Determine the impact of treatment on quality of life and disability measures [ Time Frame: 12, 26, 40, and 52 week post-activation ] [ Designated as safety issue: No ]
  • Migraine Frequency and Severity [ Time Frame: 26, 40, and 52 week post-activation ] [ Designated as safety issue: No ]
  • Medication Use [ Time Frame: 26, 40, and 52 week post-activation ] [ Designated as safety issue: No ]
  • Headache Frequency [ Time Frame: 12, 26, 40, and 52 week post-activation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Occipital Nerve Stimulation for Drug Refractory Migraine
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
Device: Precision
Implantable Neurostimulator
  • 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.
    Intervention: Device: Precision
  • Sham Comparator: 2
    Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
    Intervention: Device: Precision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
May 2012
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00747812
PRISM-UK-05
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Peter J. Goadsby, MD Royal Free Hospital NHS Foundation Trust
Boston Scientific Corporation
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP