EpilepsyPuLsE 2NCT01281280
PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1
An observational study of Epilepsy, run by Cyberonics, Inc. at 18 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 81 participants
- Where
- 18 sitesin 7 countries
- Study dates
- Mar 2011to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Italy6 sites
Azienda Ospedaliero Universitaria
Ancona
Universita di Bologna
Bologna
Universita di Pisa
Pisa
Azienda Ospedialiera "Bianchi Melacrino Morelli"
Reggio Calabria
Unisersita Cattolica Del Sacro Cuore
Rome
Centro Epilessia
Torino
France4 sites
CHU Grenoble
Grenoble
Hopital Roger Salengro Service de Neurologie
Lille
Hopital Neurologique Unite d' epileptologie
Lyon
Hopital Gui De Chauliac
Montpellier
Canada2 sites
QE2 Health Sciences Centre Department of Neurology
Halifax
Hopital Notre Dame
Montreal
Germany2 sites
Universitatskliniken Bonn
Bonn
Universitatsklinl Erlangen Zentrum fur Epilepsie
Erlangen
United Kingdom1 site
The National Hospital for Neurology and Neurosurgery
London
About this study
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
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.
Read the 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.
- Conditions
- Epilepsy
- Keywords
- PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VNS Therapy | Not described | |
| Best Medical Practice | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 5 years
Change from baseline at all follow-up visits across all health outcome measurements
Measured: 5 years
Evaluation of safety and tolerability
Measured: 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)
Measured: 5 Years
Sub-analysis to evaluate the change from baseline on quality of life
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Ryvlin, MD, Principal investigator, Unité d'épileptologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281280
- Sponsor's protocol ID
- Epilepsy (E)-101
- Other IDs
- E-101 PuLsE 2
- Acronym
- PuLsE 2
- Status last verified
- Oct 2014
- First submitted
- 19 Jan 2011
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01281280
- Acronym / sponsor ID
- PuLsE 2 / Epilepsy (E)-101
- Conditions
- Epilepsy
- Keywords
- PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS Therapy | – | – |
| Best Medical Practice | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exploratory evaluations
Time frame: 5 years
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 secondary outcomes
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
Change from baseline at all follow-up visits across all health outcome measurements
Time frame: 5 years
Evaluation of safety and tolerability
Time frame: 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)
Time frame: 5 Years
Sub-analysis to evaluate the change from baseline on quality of life
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Ryvlin, MD principal investigator
Unité d'épileptologie
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Cyberonics, Inc. at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, France, Belgium, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory evaluations (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.