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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
Results First Received: June 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine
Intervention: Device: Precision

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Stimulation (Treatment Group) 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 (Control Group) Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.

Participant Flow:   Overall Study
    Active Stimulation (Treatment Group)     Sham Stimulation (Control Group)  
STARTED     5     3 [1]
COMPLETED     0     0  
NOT COMPLETED     5     3  
Research Site Staff Relocation                 5                 3  
[1] 4 subjects were randomized to the Control Group; 1 was not implanted due to early enrollment closure



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Stimulation (Treatment Group) 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 (Control Group) Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
Total Total of all reporting groups

Baseline Measures
    Active Stimulation (Treatment Group)     Sham Stimulation (Control Group)     Total  
Number of Participants  
[units: participants]
  5     3     8  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 15.5     55.6  ± 5.5     50.7  ± 12.7  
Gender  
[units: participants]
     
Female     4     2     6  
Male     1     1     2  
Region of Enrollment  
[units: participants]
     
United Kingdom     5     3     8  



  Outcome Measures
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1.  Primary:   Number of Hours of Headache   [ Time Frame: 12 weeks ]

2.  Primary:   Number of Days With 4 or More Hours of Headache   [ Time Frame: 12 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Insufficient data collected from limited number of implanted subjects.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lyn Pimentel, Clinical Project Manager
Organization: Boston Scientific
phone: (661) 949-4174
e-mail: Lyn.Pimentel@bsci.com


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