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Treatment for Migraines With an Implantable Device

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00286078
First received: February 1, 2006
Last updated: June 28, 2016
Last verified: June 2016
Results First Received: April 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel 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
179 subjects signed consent, 39 subjects screen failed, and 140 eligible subjects were randomized.

Reporting Groups
  Description
Treatment

Stimulation on

Precision: Implantable neurostimulator

Control

Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.

Precision: Implantable neurostimulator


Participant Flow:   Overall Study
    Treatment     Control  
STARTED     72     68  
12 Weeks     63     62  
COMPLETED     40     34  
NOT COMPLETED     32     34  



  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.
1 subject excluded from analysis because HIPAA authorization was not obtained; randomized to active group, received percutaneous trial only

Reporting Groups
  Description
Treatment

Stimulation on

Precision: Implantable neurostimulator

Control

Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.

Precision: Implantable neurostimulator

Total Total of all reporting groups

Baseline Measures
    Treatment     Control     Total  
Number of Participants  
[units: participants]
  71     68     139  
Age  
[units: years]
Mean (Standard Deviation)
  41.5  (11.2)     43.8  (11.9)     42.6  (11.6)  
Gender  
[units: participants]
     
Female     60     57     117  
Male     11     11     22  
Region of Enrollment  
[units: participants]
     
United States     71     68     139  



  Outcome Measures
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1.  Primary:   Migraine Frequency at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]

2.  Primary:   Frequency of Adverse Event   [ Time Frame: 26 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
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  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: Clinical Research Information
Organization: Boston Scientific
phone: 855-213-9890
e-mail: BSNClinicalTrials@bsci.com



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00286078     History of Changes
Other Study ID Numbers: EI0105
Study First Received: February 1, 2006
Results First Received: April 6, 2016
Last Updated: June 28, 2016
Health Authority: United States: Food and Drug Administration