PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1 (PuLsE 2)
|ClinicalTrials.gov Identifier: NCT01281280|
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : October 16, 2014
|Condition or disease|
In 2005 Cyberonics, Inc. initiated PuLsE: an open, prospective, randomized, parallel group study directly comparing Best Medical Practice with and without adjunctive VNS Therapy.
In July 2008, the decision was made to discontinue this study due to lower than expected enrolment, impairing the possibility to meet the primary objective with appropriate statistical power. However, the relatively large number of participants (n=121) randomized in the original PuLsE study offers the possibility to generate scientifically valuable and original findings if additional follow-up data can be gathered. After consultation with the PuLsE Investigators, Cyberonics decided to implement an observational long-term follow-up of the participants enrolled in the original PuLsE study.
|Study Type :||Observational|
|Actual Enrollment :||81 participants|
|Official Title:||A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants With Drug-resistant Epilepsy With Partial-onset Seizures Previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice With or w/o Adjunctive Vagus Nerve Stimulation Therapy|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||April 2014|
|Best Medical Practice|
- Exploratory evaluations [ Time Frame: 5 years ]The objective of this post-market study is to perform exploratory evaluations to identify clinically and statistically significant predictors of response at all follow-up visits in participants with drug-resistant epilepsy with partial-onset seizures treated with Best Medical Practice with or without adjunctive VNS Therapy. This will be accomplished through regression modeling of the response variates (including change in baseline quality of life score and percent reduction in seizure frequency).
- Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice [ Time Frame: 5 years ]
- Change from baseline at all follow-up visits across all health outcome measurements [ Time Frame: 5 years ]
- Evaluation of safety and tolerability [ Time Frame: 5 Years ]
- Evaluation of change from baseline at all follow-up visits of Best Medical Practice with and without adjunctive VNS Therapy on health outcome measurements and quality of life (QOL) [ Time Frame: 5 Years ]
- Sub-analysis to evaluate the change from baseline on quality of life [ Time Frame: 5 Years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281280
|Principal Investigator:||Philippe Ryvlin, MD||Unité d'épileptologie|