Clinical trial NCT01281280: PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 81
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Exploratory evaluations
timeFrame: 5 years
Secondary outcomes:
measure: Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice
timeFrame: 5 years
measure: Change from baseline at all follow-up visits across all health outcome measurements
timeFrame: 5 years
measure: Evaluation of safety and tolerability
timeFrame: 5 Years
measure: 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)
timeFrame: 5 Years
measure: Sub-analysis to evaluate the change from baseline on quality of life
timeFrame: 5 Years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Hopital Erasme
city: Gent
country: Belgium
facility: UZ Gent
city: Halifax
country: Canada
facility: QE2 Health Sciences Centre Department of Neurology
city: Montreal
country: Canada
facility: Hopital Notre Dame
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille Cedex
country: France
facility: Hopital Roger Salengro Service de Neurologie
city: Lyon
country: France
facility: Hopital Neurologique Unite d' epileptologie
city: Montpellier
country: France
facility: Hopital Gui De Chauliac
city: Bonn
country: Germany
facility: Universitatskliniken Bonn
city: Erlangen
country: Germany
facility: Universitatsklinl Erlangen Zentrum fur Epilepsie
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria
city: Bologna
country: Italy
facility: Universita di Bologna
city: Pisa
country: Italy
facility: Universita di Pisa
city: Reggio Calabria
country: Italy
facility: Azienda Ospedialiera "Bianchi Melacrino Morelli"
city: Rome
country: Italy
facility: Unisersita Cattolica Del Sacro Cuore
city: Torino
country: Italy
facility: Centro Epilessia
city: Oosterhout
country: Netherlands
facility: Hans Berger kliniek Neurology
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
Study officials:
affiliation: Unité d'épileptologie
name: Philippe Ryvlin, MD
role: PRINCIPAL_INVESTIGATOR
References: