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

NCT01281280 | Completed

• 2 other identifiers: Epilepsy (E)-101E-101 PuLsE 2
• Study Type: observational
• Target: 81
• Locations: 7 countries
• Sites: 18

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.

Conditions

Epilepsy

Keywords

PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice

  5 years

• Change from baseline at all follow-up visits across all health outcome measurements

  5 years

• Evaluation of safety and tolerability

  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)

  5 Years

• Sub-analysis to evaluate the change from baseline on quality of life

  5 Years

Study Arms (2)

VNS Therapy

Best Medical Practice

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• To be eligible for the study, the participant must meet all the following criteria:
• Participant must have been randomized in the original PuLsE study.
• Participant must have baseline data from the original PuLsE study.
• Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
• 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.

You may not qualify if:

• The presence of any of the following will exclude a participant from the study:
• Participant has a history of non-compliance with the completion of a seizure diary.
• Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• Participant is expected to require full body magnetic resonance imaging during the clinical study.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (18)

ULB Hopital Erasme

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

QE2 Health Sciences Centre Department of Neurology

Halifax, Canada

Location

Hopital Notre Dame

Montreal, Canada

Location

CHU Grenoble

Grenoble, France

Location

Hopital Roger Salengro Service de Neurologie

Lille, France

Location

Hopital Neurologique Unite d' epileptologie

Lyon, France

Location

Hopital Gui De Chauliac

Montpellier, France

Location

Universitatskliniken Bonn

Bonn, Germany

Location

Universitatsklinl Erlangen Zentrum fur Epilepsie

Erlangen, Germany

Location

Azienda Ospedaliero Universitaria

Ancona, Italy

Location

Universita di Bologna

Bologna, Italy

Location

Universita di Pisa

Pisa, Italy

Location

Azienda Ospedialiera "Bianchi Melacrino Morelli"

Reggio Calabria, Italy

Location

Unisersita Cattolica Del Sacro Cuore

Rome, Italy

Location

Centro Epilessia

Torino, Italy

Location

Hans Berger kliniek Neurology

Oosterhout, Netherlands

Location

The National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Philippe Ryvlin, MD

  Unité d'épileptologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 21, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

BE (2); CA (2); IT (6); GB (1); DE (2); NL (1); FR (4)