Lead Investigator: Lucy Vivash, Monash University
Title of Proposal Research: Evaluation of epilepsy-DOOR (Desirability of outcome ranking) as an outcome measure for therapeutic trials in drug resistant epilepsy
Vivli Data Request: 9350
Funding Source: Investigator time will be funded via grants and fellowships to the investigators for related work
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Epilepsy is a common neurological disorder which causes seizures and affects ~1% of the general population. Despite the availability of numerous anti-seizure medications, a significant proportion of patients are not well controlled by the currently available treatments and continue to have seizures. Epilepsy is not only associated with ongoing seizures, but people with epilepsy can also experience anxiety and depression and cognitive deficits (the ability to clearly think, learn and remember).
Current clinical trials in people with epilepsy who haven’t responded to existing treatments (drug resistant epilepsy) are commonly powered to detect a 50% reduction in seizure frequency, without consideration for other impacts that may be experienced by patients when commencing a new treatment such as side effects and worsening of cognitive deficits or mood disturbances.
The epilepsy-DOOR (Desirability of outcome ranking) is a new methodology which evaluates seizure frequency, side effects and overall quality of life measures to provide a more holistic measure of potential benefits and harms and reflects the preferences of people with epilepsy when considering trade-offs between these aspects of patient outcomes.
It aims to provide a more comprehensive measure of potential benefits and harms associated with a new therapy for people with epilepsy.
This study seeks to use data collected from previous clinical trials to evaluate the feasibility of epilepsy-DOOR as a potential new outcome measure for use in future therapeutic trials in drug resistant epilepsy.
Requested Studies:
An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
Data Contributor: UCB
Study ID: NCT00504881
Sponsor ID: N01254
A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Data Contributor: UCB
Study ID: NCT00490035
Sponsor ID: N01252
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT00464269
Sponsor ID: N01253