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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01281280
First received: January 19, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
VNS Therapy
Best Medical Practice

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281280

Locations
Belgium
ULB Hopital Erasme
Brussels, Belgium
UZ Gent
Gent, Belgium
Canada
QE2 Health Sciences Centre Department of Neurology
Halifax, Canada
Hopital Notre Dame
Montreal, Canada
France
CHU Grenoble
Grenoble, France
Hopital Roger Salengro Service de Neurologie
Lille Cedex, France
Hopital Neurologique Unite d' epileptologie
Lyon, France
Hopital Gui De Chauliac
Montpellier, France
Germany
Universitatskliniken Bonn
Bonn, Germany
Universitatsklinl Erlangen Zentrum fur Epilepsie
Erlangen, Germany
Italy
Azienda Ospedaliero Universitaria
Ancona, Italy
Universita di Bologna
Bologna, Italy
Universita di Pisa
Pisa, Italy
Azienda Ospedialiera "Bianchi Melacrino Morelli"
Reggio Calabria, Italy
Unisersita Cattolica Del Sacro Cuore
Rome, Italy
Centro Epilessia
Torino, Italy
Netherlands
Hans Berger kliniek Neurology
Oosterhout, Netherlands
United Kingdom
The National Hospital for Neurology and Neurosurgery
London, United Kingdom
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Principal Investigator: Philippe Ryvlin, MD Unité d'épileptologie
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01281280     History of Changes
Other Study ID Numbers: Epilepsy (E)-101, E-101 PuLsE 2
Study First Received: January 19, 2011
Last Updated: October 29, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cyberonics, Inc.:
PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014