Trobalt™ Products Risk Survey

NCT01721213 | Completed

• 2 other identifiers: 116771WEUKBRE5744
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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™.

Conditions

Epilepsy

Keywords

Epilepsy; survey; retigabine; patient information leaflet; physician's guide; Trobalt™

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (3)

Patients using Trobalt™

Use of Trobalt™ current use or at least one prescription filled within the previous three months.

Drug: Trobalt™

Physicians prescribing AEDs

Physicians (neurologists) who prescribed AEDs at least once in the three months prior to the survey.

Drug: Trobalt™

Physicians Prescribing Trobalt™

Physicians (neurologists) who have had experience of prescribing Trobalt™ specifically, from among those who have prescribed AEDs at least once in the three months prior to the survey.

Drug: Trobalt™

Interventions

Trobalt™ DRUG

Trobalt™ is a potassium channel opener used as an adjunctive treatment for partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy.

Patients using Trobalt™; Physicians Prescribing Trobalt™; Physicians prescribing AEDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A random sample of 350 patients who are currently being treated with Trobalt™or who have received Trobalt™within the last 3 months. Patients will be recruited by prescribers, who will be asked to provide survey invitations to their patients being treated with Trobalt™. A random sample of 300 neurologists prescribing anti-epileptic drug (AEDs) and who have been sent the Trobalt™ Physician's Guide. A sample of 200 neurologists will be recruited from across the same eight countries, with up to 100 neurologists from Germany. The recruitment will be from among those who have prescribed an AED at least once in the last 3 months, and who were on the list to which a letter including the Physician's Guide Trobalt™ was distributed. The survey will aim to recruit at least 75 physicians (from the seven specified countries) and 50 physicians from Germany with experience of prescribing Trobalt™ for sub-analyses, as these individuals would be expected to be more aware of the risks of Trobalt™.

You may qualify if:

• Use of Trobalt™: current use or at least one prescription filled within the previous three months.
• years of age or older.
• Willing to take the online survey or have the survey administered via a telephone interview.
• Must have prescribed an AED at least once in the last 3 months
• Must be on the list to which the Physician's Guide for Trobalt™ was distributed.

You may not qualify if:

• Patients meeting any of the following criteria will not be eligible to take the survey:
• Unable to understand and complete the survey by internet or phone.
• Currently an employee of GSK or UBC.
• Physicians meeting any of the following criteria will not be eligible to take the survey:
• \- Currently an employee of GSK or UBC.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Ishihara L, Lewis A, Kolli S, Brickel N. European Survey of Prescriber Understanding of Risks Associated with Retigabine. Drugs Real World Outcomes. 2015;2(4):345-353. doi: 10.1007/s40801-015-0044-3. Epub 2015 Nov 16.

  PMID: 26688787 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: November 5, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2015-01