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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:
ClinicalTrials.gov Identifier:
NCT00522418
First Posted: August 29, 2007
Last Update Posted: January 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cyberonics, Inc.
Results First Submitted: April 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. There were 9 screen failures out of 131 screened patients, leaving 122 patients who started the study and are described in the Participant Flow.

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 
Safety Set   54 [1]   58 [1] 
Efficacy Set   48 [2]   48 [3] 
Baseline and Month 3   47 [4]   47 [4] 
Baseline and Month 6   38 [5]   45 [5] 
Baseline and Month 9   33 [6]   35 [6] 
Baseline and Month 12   31 [7]   29 [7] 
COMPLETED   2 [8]   5 [8] 
NOT COMPLETED   57   58 
Local IRB Consent Violation                5                5 
Early Study Termination                46                47 
Noncompliance                2                2 
Reason Not Specified                3                1 
Consent Withdraw                1                2 
Lack of Efficacy                0                1 
[1] Data of 5 randomized patients removed due to lack of ICF approval by site’s local ethics committee.
[2] 6 pts. data excluded: exited prior to collection of baseline data & one postbaseline followup QOLIE
[3] 10 pts. data excluded: exited prior to collection of baseline data & one postbaseline followup QOLIE
[4] Completed Baseline and Month 3
[5] Completed Baseline and Month 6
[6] Completed Baseline and Month 9
[7] Completed Baseline and Month 12
[8] Completed 2-year follow-up



  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.
All participants who completed the baseline assessment and at least one postbaseline follow-up QOLIE-89 assessment, and met local IRB consent requirements

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 
Overall Participants Analyzed 
[Units: Participants]
 48   48   96 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 38  (13)   41  (11)   40  (12) 
[1] Age at Randomization
Gender 
[Units: Participants]
     
Female   24   21   45 
Male   24   27   51 
Age of Epilepsy Onset 
[Units: Years]
Mean (Standard Deviation)
 13  (14)   16  (14)   15  (14) 
Etiology of Epilepsy 
[Units: Participants]
     
Structural/Metabolic   26   26   52 
Unknown   22   22   44 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment   [ Time Frame: Mean change from baseline QOLIE-89 Overall Score at 12 months ]

2.  Secondary:   Response Rate   [ Time Frame: Number of Responders at 12 Months ]

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

4.  Secondary:   Mean Percent Change in Seizure Frequency   [ Time Frame: Mean percent change from baseline in seizure frequency at 12 months ]

5.  Secondary:   Seizure Free Days   [ Time Frame: From the patient's last seizure to the study exit date ]

6.  Secondary:   Seizure Free Days Over the Last 6 Months   [ Time Frame: Over the last 6 months ]

7.  Secondary:   Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score   [ Time Frame: Mean change from baseline CES-D Score at 12 months ]

8.  Secondary:   Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score   [ Time Frame: Mean change from baseline NDDI-E Score at 12 months ]

9.  Secondary:   Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months   [ Time Frame: Mean change from baseline CGI-I Score at 12 months ]

10.  Secondary:   Change From Baseline in Adverse Event Profile (AEP) Score   [ Time Frame: Mean change from baseline AEP Score at 12 months ]

11.  Secondary:   Changes in Anti-epileptic Drugs (AEDs)   [ Time Frame: Change from baseline in number of AEDs at 12 months ]

12.  Secondary:   Retention Rate   [ Time Frame: At 12 and 24 months ]

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

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 ]

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 ]

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 ]

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

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

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

20.  Secondary:   Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40   [ Time Frame: Change from baseline up to 12 months ]

21.  Secondary:   Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40   [ Time Frame: Change from baseline up to 12 months ]

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


  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
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.


  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.


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


Publications of Results:
Other Publications:


Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT00522418     History of Changes
Other Study ID Numbers: E-100
First Submitted: August 27, 2007
First Posted: August 29, 2007
Results First Submitted: April 2, 2010
Results First Posted: May 17, 2010
Last Update Posted: January 26, 2015