As part of a European post-marketing commitment, GSK will conduct a survey of physicians' and
patients' understanding of the significant risks associated with Trobalt™ (retigabine), as
described in the Patient Information Leaflet (PIL) and the Physician's Guide. The goal of the
surveys is to evaluate the effectiveness of the educational plan as specified in the European
Risk Management Plan (RMP).
The objectives of this study are to assess patients' and prescribers' understanding and
knowledge of the significant risks associated with Trobalt™ use as evaluated by a survey
instrument.
This is a cross sectional survey of:
1. 250 patients recruited from across the following countries (United Kingdom, Sweden,
Denmark, Switzerland, Spain, Slovakia and Norway) and up to 100 patients from Germany
who are currently using or have filled a prescription for Trobalt™ at least once in the
last 3 months.
2. 200 neurologists who have prescribed an anti-epileptic drug (AED) at least once in the
last 3 months, and who were on the list to which a letter containing the Physician's
Guide for Trobalt™ was distributed from across the following countries (United Kingdom,
Sweden, Denmark, Switzerland, Spain, Slovakia and Norway). At least 75 of the
neurologists will have prescribed Trobalt™. The survey will also aim to include up to
100 neurologists from Germany of which approximately 50 will have prescribed Trobalt™.
Patients eligible for the survey will be asked to take the survey online or via a telephone
interview if the latter is preferred. Neurologists will be invited to take the survey online.
The selected countries were the first five countries to launch Trobalt™ (Germany, Denmark,
United Kingdom, Switzerland and Sweden) and an additional three countries with launch in
2011, but with relatively high rates of uptake of Trobalt™ (Spain, Slovakia and Norway). The
selection of countries includes Switzerland, which is not part of the European Union.
However, the key messages regarding the risks with Trobalt™ are in alignment. The rationale
for surveying the first five countries to launch is so that any issues identified from these
countries regarding the effectiveness of the Physician's Guide and PIL in communicating the
risks of Trobalt™ can be addressed as soon as possible, and the key messages can be revised
in a timely manner. In addition, these countries are likely to provide the greatest number of
neurologists with experience of prescribing Trobalt™, and their patients.
The primary outcome of the survey is the proportion of patients/neurologists providing
correct responses to a series of questions concerning the significant risks associated with
Trobalt™. The risks evaluated will be those described in the Trobalt™ PIL and in the
Physician's Guide.