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Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT00522418
First received: August 27, 2007
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
Results First Received: April 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epilepsy
Partial Epilepsy
Interventions: Device: Vagal Nerve Simulation (VNS) Therapy
Drug: Best Medical Practive

  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
This study was started in February 2006 at 41 sites and terminated on July 28, 2008 as a result of a decision by Cyberonics, Inc. The decision to terminate the study was primarily due to insufficient enrollment. The decision was not the result of a safety or efficacy signal.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized in a 1:1 ratio to the Best Medical Practice With Adjunctive VNS Therapy study group or to the Best Medical Practice Without VNS Therapy study group. VNS Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.

Reporting Groups
  Description
VNS Therapy VNS Therapy + Best Medical Practice
Best Medical Practice Best Medical Practice Without VNS Therapy

Participant Flow:   Overall Study
    VNS Therapy     Best Medical Practice  
STARTED     59     63  
COMPLETED     2     4  
NOT COMPLETED     57     59  
Consent Withdraw                 1                 2  
Treatment Failure                 0                 1  
Subject Nonadherence                 3                 2  
Protocol Nonadherence                 4                 5  
Study Termination                 47                 48  
Not Specified                 1                 1  
Lack of Baseline data                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
VNS Therapy VNS Therapy + Best Medical Practice
Best Medical Practice Best Medical Practice Without VNS Therapy
Total Total of all reporting groups

Baseline Measures
    VNS Therapy     Best Medical Practice     Total  
Number of Participants  
[units: participants]
 		  59     63     122  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  38.1  ± 11.9     41.3  ± 11.5     39.7  ± 11.8  
Gender  
[units: participants]
 		     
Female     29     28     57  
Male     30     35     65  
Epilepsy Etiology  
[units: participants]
 		     
Idiopathic     0     0     0  
Symptomatic     30     31     61  
Cryptogenic     29     32     61  
Simple Partial Seizures [2]
[units: patients]
 		     
No     38     34     72  
Yes     17     28     45  
Unknown     4     1     5  
Age of Epilepsy Onset [3]
[units: years]
Mean ± Standard Deviation 		  12.5  ± 12.5     15.5  ± 12.5     14.0  ± 12.6  
Blood Pressure - Diastolic [4]
[units: Millimeters of mercury (mmHg)]
Mean ± Standard Deviation 		  77.1  ± 8.0     78.4  ± 8.6     77.8  ± 8.3  
Blood Pressure - Systolic [4]
[units: Millimeters of mercury (mmHg)]
Mean ± Standard Deviation 		  125.2  ± 12.6     125.5  ± 11.7     125.3  ± 12.1  
Heart Rate [3]
[units: Beats per minute]
Mean ± Standard Deviation 		  74.9  ± 7.8     73.0  ± 6.5     73.9  ± 7.2  
Height [5]
[units: centimeters (cm)]
Mean ± Standard Deviation 		  169.7  ± 9.1     171.4  ± 10.9     170.6  ± 10.1  
Weight [5]
[units: kilogram (kg)]
Mean ± Standard Deviation 		  72.4  ± 14.5     76.0  ± 19.4     74.3  ± 17.2  
[1] Age at Randomization
[2] Data available for 55/59 of VNS Therapy Group and 62/63 of Best Medical Practice Group.
[3] Data available for 58/59 of VNS Therapy Group and 61/63 of Best Medical Practice Group.
[4] Data available for 59/59 of VNS Therapy Group and 61/63 of Best Medical Practice Group.
[5] Data available for 59/59 of VNS Therapy Group and 62/63 of Best Medical Practice Group.



  Outcome Measures
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1.  Primary:   Quality of Life in Epilepsy (QOLIE-89)   [ Time Frame: Mean score at 21 and 24 months ]
  Show Outcome Measure 1

2.  Secondary:   Response Rate   [ Time Frame: 3, 6 , 9, 12, 15, 18, 21, and 24 months ]
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Measure Type Secondary
Measure Title Response Rate
Measure Description Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.
Time Frame 3, 6 , 9, 12, 15, 18, 21, and 24 months  
Safety Issue No  

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.
This study was started in February 2006 at 41 sites and terminated on July 28, 2008, at 122 of 362 planned patients as a result of a decision by Cyberonics, Inc. The decision to terminate the study was primarily due to insufficient enrollment. The decision was not the result of a safety or efficacy signal.

Reporting Groups
  Description
VNS Therapy VNS Therapy + Best Medical Practice
Best Medical Practice Best Medical Practice Without VNS Therapy

Measured Values
    VNS Therapy     Best Medical Practice  
Number of Participants Analyzed  
[units: participants]
 		  0     0  
Response Rate          

No statistical analysis provided for Response Rate



3.  Secondary:   Percent of Patients That Are Seizure Free   [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months ]
  Show Outcome Measure 3

4.  Secondary:   Mean Percent Change in Seizure Frequency   [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months ]
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5.  Secondary:   Seizure Free Days   [ Time Frame: From the patient's last seizure to the study exit date ]
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6.  Secondary:   Seizure Free Days Over the Last 6 Months   [ Time Frame: Over the last 6 months ]
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7.  Secondary:   Center for Epidemiologic Studies Depression Scale (CES-D)   [ Time Frame: At 12 and 24 months ]
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8.  Secondary:   Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)   [ Time Frame: At 12 and 24 months ]
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9.  Secondary:   Clinical Global Impressions Scale (CGI)   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 9

10.  Secondary:   Adverse Event Profile (AEP)   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 10

11.  Secondary:   Changes in Anti-epileptic Drugs (AEDs)   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 11

12.  Secondary:   Retention Rate   [ Time Frame: At 12 and 24 months ]
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13.  Secondary:   Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 13

14.  Secondary:   Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 14

15.  Secondary:   Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 15

16.  Secondary:   Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 16

17.  Secondary:   Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 17

18.  Secondary:   Change in the Number of Anti-epileptic Drugs Prescribed   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 18

19.  Secondary:   Percent of Participants Who Were Compliant With the Protocol   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 19

20.  Secondary:   Quality of Life in Epilepsy-89 (QOLIE-89) in Patients With a Baseline AEP Score Less Than 40 Versus Those Patients With a Baseline AEP Score Greater Than or Equal to 40   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 20

21.  Secondary:   Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures   [ Time Frame: At 12 and 24 months ]
  Show Outcome Measure 21


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
This study was terminated as a result of a decision by Cyberonics, Inc. The decision to terminate the study was primarily due to insufficient enrollment. The decision was not the result of a safety or efficacy signal.  


Results Point of Contact:  
Name/Title: Senior Director, Global Medical Affairs
Organization: Cyberonics, Inc
phone: 281-228-7223
e-mail: Mark.Bunker@cyberonics.com


Publications:


Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT00522418     History of Changes
Other Study ID Numbers: E-100
Study First Received: August 27, 2007
Results First Received: April 2, 2010
Last Updated: October 22, 2012
Health Authority: Belgium: Institutional Review Board
Canada: Ethics Review Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Norway:National Committee for Medical and Health Research Ethics
Spain: Comité Ético de Investigación Clínica
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee