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 without Adjunctive Vagus Nerve Stimulation Therapy.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26412

Enrollment

121

Registered

2011-03-01

Start date

2011-02-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory epilepsy, Vagus Nerve Stimulation, VNS, NVS, Nervus Vagus Stimulatie, refractaire epilepsie

Interventions

Participants who took part in the original PuLsE study and who have baseline data will be contacted by the Investigator to request participation in the follow-up study (PuLsE2). The randomization date

therefore, baseline data obtained in the original PuLsE study will also serve as baseline for the PuLsE2 study. This study will have a maximum of 5 visits including a screening visit and 3-4 follow-

2. Follow-up visits (Visits 2-5): Three months prior to each participant’s follow-up visit, the study site will contact the participant as a courtesy to remind the participant to begin completing thei

Eligibility

Inclusion 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 PuLsE2 in accordance with institutional and local regulatory policies. Participant must sign informed consent within 9 months of submission to the study site’s Ethics Committee.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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). Predictors will include, but will not be limited to: 1. General demographics: age, gender, ethnicity; 2. Disease-specific demographics such as etiology, age at onset, seizure type; 3. Treatment group (Best Medical Practice without VNS Therapy or Best Medical Practice with adjunctive VNS Therapy); 4. Baseline values of health outcomes (quality of life, seizure frequency, comorbid depression, and adverse event profile).	—

Measure

Time frame

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). Predictors will include, but will not be limited to: 1. General demographics: age, gender, ethnicity; 2. Disease-specific demographics such as etiology, age at onset, seizure type; 3. Treatment group (Best Medical Practice without VNS Therapy or Best Medical Practice with adjunctive VNS Therapy); 4. Baseline values of health outcomes (quality of life, seizure frequency, comorbid depression, and adverse event profile).

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Secondary

Measure	Time frame
1. To evaluate the change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice without VNS Therapy in participants with drug-resistant epilepsy with partial-onset seizures as measured by: A. Response rates (greater than or equal to 50% reduction in seizures compared to baseline) at all follow-up visits; B. Response rates (greater than or equal to 75% reduction in seizures compared to baseline) at all follow-up visits; C. Percent of participants that are seizure free for at least one year at all follow-up visits; D. Mean and median percent change in seizure frequency (in total and by seizure type) at all follow-up visits; E. Seizure free days: time from last seizure to study exit date, and seizure free days over the last 3 months. 2. To evaluate the change from baseline at all follow-up visits across all health outcome measurements (including quality of life, seizure frequency, comorbid depression, and adverse event profile) for Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice without VNS Therapy; 3. To evaluate the safety and tolerability of Best Medical Practice with adjunctive VNS Therapy using information on treatment emergent adverse events and device complications at all visits; 4. To evaluate the 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) in participants with drug-resistant epilepsy with partial-onset seizures and less then a 50% reduction in seizures (non-responders); 5. A sub-analysis may be performed to evaluate the change from baseline on quality of life for participants with a baseline Adverse Event Profile (AEP) score less than 40 compared to participants with a baseline AEP score greater than or equal to 40.	—

Measure

Time frame

1. To evaluate the change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice without VNS Therapy in participants with drug-resistant epilepsy with partial-onset seizures as measured by: A. Response rates (greater than or equal to 50% reduction in seizures compared to baseline) at all follow-up visits; B. Response rates (greater than or equal to 75% reduction in seizures compared to baseline) at all follow-up visits; C. Percent of participants that are seizure free for at least one year at all follow-up visits; D. Mean and median percent change in seizure frequency (in total and by seizure type) at all follow-up visits; E. Seizure free days: time from last seizure to study exit date, and seizure free days over the last 3 months. 2. To evaluate the change from baseline at all follow-up visits across all health outcome measurements (including quality of life, seizure frequency, comorbid depression, and adverse event profile) for Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice without VNS Therapy; 3. To evaluate the safety and tolerability of Best Medical Practice with adjunctive VNS Therapy using information on treatment emergent adverse events and device complications at all visits; 4. To evaluate the 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) in participants with drug-resistant epilepsy with partial-onset seizures and less then a 50% reduction in seizures (non-responders); 5. A sub-analysis may be performed to evaluate the change from baseline on quality of life for participants with a baseline Adverse Event Profile (AEP) score less than 40 compared to participants with a baseline AEP score greater than or equal to 40.

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Contacts

Public ContactMark Bunker

Cyberonics Inc 100 Cyberonics Blvd

Mark.bunker@cyberonics.com+1 281 2287223

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)