Skip to main content
OpenTrials
Completed

NCT Number: NCT01098162

Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

55, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®
  • The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study
  • The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient
  • The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures
  • Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®

Exclusion criteria

In accordance with the Summary of Product Characteristics (SmPC)

Treatment and study plan

Primary outcomes

  1. Clinical Global Impression of Change (CGI-C) at Month 6

    Time frame: Month 6

    For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:

    • Very much improved
    • Much improved
    • Minimally improved
    • No change
    • Minimally worse
    • Much worse
    • Very much worse

Secondary outcomes

  1. Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3

    Time frame: From Baseline to Month 3

    Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.

    Change in number of partial-onset seizures was derived as follows:

    Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).

    A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.

    Partial-onset seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  2. Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6

    Time frame: From Baseline to Month 6

    Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.

    Change in number of partial-onset seizures was derived as follows:

    Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).

    A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.

    Partial-onset seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  3. Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3

    Time frame: From Baseline to Month 3

    Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.

    Change in number of partial-onset seizures with secondary generalization was derived as follows:

    Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).

    A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.

    Partial-onset seizures with secondary generalization can be classified into one of the following three groups:

    • Simple partial seizures evolving to generalized seizures
    • Complex partial seizures evolving to generalized seizures
    • Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.

  4. Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6

    Time frame: From Baseline to Month 6

    Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.

    Change in number of partial-onset seizures with secondary generalization was derived as follows:

    Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).

    A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.

    Partial-onset seizures with secondary generalization can be classified into one of the following three groups:

    • Simple partial seizures evolving to generalized seizures
    • Complex partial seizures evolving to generalized seizures
    • Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.

  5. Incidence of Adverse Events During the Study

    Time frame: From Inclusion Visit (Day 0) up to Month 6

    The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.

Sponsors and collaborators

Lead sponsor

UCB Pharma GmbH

Industry

Registry information

Official study title

A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany

Acronym: VITOBA

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2010
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.