PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01281280
First received: January 19, 2011
Last updated: October 14, 2014
Last verified: October 2014

January 19, 2011
October 14, 2014
March 2011
October 2013   (final data collection date for primary outcome measure)
Exploratory evaluations [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01281280 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline at all follow-up visits across all health outcome measurements [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluation of safety and tolerability [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sub-analysis to evaluate the change from baseline on quality of life [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    To evaluate the change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice without VNS Therapy in participants with drug-resistant epilepsy with partial-onset seizure.
  • Change from baseline at all follow-up visits across all health outcome measurements [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate the change from baseline at all follow-up visits across all health outcome measurements (including quality of life, seizure frequency, comorbid depression, and adverse event profile) for Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice without VNS Therapy.
  • Evaluation of safety and tolerability [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    To evaluate the safety and tolerability of Best Medical Practice with adjunctive VNS Therapy using information on treatment emergent adverse events and device complications at all visits.
  • 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 ] [ Designated as safety issue: No ]
    To evaluate the 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) in participants with drug-resistant epilepsy with partial-onset seizures and less then a 50% reduction in seizures (non-responders).
  • Sub-analysis to evaluate the change from baseline on quality of life [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    A sub-analysis may be performed to evaluate the change from baseline on quality of life for participants with a baseline Adverse Event Profile (AEP) score less than 40 compared to participants with a baseline AEP score greater than or equal to 40.
Not Provided
Not Provided
 
PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1
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

This is 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 (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The study population will consist of participants previously enrolled in the original PuLsE study diagnosed with drug-resistant epilepsy with partial-onset seizures. All patients will be analyzed according to the treatment that they have actually received and followed in this new study regardless of what treatment groups they were randomized in the previous study.

Epilepsy
Not Provided
  • VNS Therapy
  • Best Medical Practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
April 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be eligible for the study, the participant must meet all the following criteria:

  1. Participant must have been randomized in the original PuLsE study.
  2. Participant must have baseline data from the original PuLsE study.
  3. Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
  4. Participant or legal guardian understands study procedures and has voluntarily signed an informed consent for PuLsE 2 in accordance with institutional and local regulatory policies.

Exclusion Criteria:

The presence of any of the following will exclude a participant from the study:

  1. Participant has a history of non-compliance with the completion of a seizure diary.
  2. Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
  3. Participant is expected to require full body magnetic resonance imaging during the clinical study.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   France,   Netherlands,   Canada,   United Kingdom,   Belgium,   Germany
 
NCT01281280
Epilepsy (E)-101, E-101 PuLsE 2
No
Cyberonics, Inc.
Cyberonics, Inc.
Not Provided
Principal Investigator: Philippe Ryvlin, MD Unité d'épileptologie
Cyberonics, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP