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

Epilepsy Clinical Trial

— PuLsE 2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281280
• Other study ID #: Epilepsy (E)-101
• Secondary ID: E-101 PuLsE 2
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: October 14, 2014
• Start date: March 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Belgium	ULB Hopital Erasme	Brussels
Belgium	UZ Gent	Gent
Canada	QE2 Health Sciences Centre Department of Neurology	Halifax
Canada	Hopital Notre Dame	Montreal
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
Germany	Universitatskliniken Bonn	Bonn
Germany	Universitatsklinl Erlangen Zentrum fur Epilepsie	Erlangen
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
Netherlands	Hans Berger kliniek Neurology	Oosterhout
United Kingdom	The National Hospital for Neurology and Neurosurgery	London

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploratory evaluations	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).	5 years	No
Secondary	Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice		5 years	No
Secondary	Change from baseline at all follow-up visits across all health outcome measurements		5 years	No
Secondary	Evaluation of safety and tolerability		5 Years	No
Secondary	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)		5 Years	No
Secondary	Sub-analysis to evaluate the change from baseline on quality of life		5 Years	No