Last updated: 11/03/2018 18:16:54

Retigabine Observational Study in Epilepsy (ROSE) StudyROSE

GSK study ID
115587
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Retigabine Observational Study in Epilepsy (ROSE) Study
Trial description: This observational study will collect real-world data related to retigabine treatment in patients diagnosed with partial-onset epilepsy. A total of 800 patients located in Europe will be enrolled and followed for 12 months. Time of enrolment will coincide with initial treatment with retigabine for all patients. Throughout the study, data will be collected to evaluate the real-world efficacy and safety of retigabine. Additional data will be collected to better understand titration of and adherence to retigabine therapy in the real-world setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Retention rate of subjects from baseline through 12 months

Timeframe: 12 months

Secondary outcomes:

Change in QOLIE 10-P from baseline to the end of study

Timeframe: 12 months

Change in MMAS-8 from baseline to the end of study

Timeframe: 12 months

Number and duration of hospitalisations and health care provider visits throughout the study and in the 12 months prior to enrolment

Timeframe: 12 months

Distribution and prescribed dose of background AEDs at 3, 6, 9, and 12 months

Timeframe: 12 months

Number of seizure-free subjects for any 3, 6, 9, and 12 continuous months during the course of the study

Timeframe: 12 months

Incidence of AEs and SAEs

Timeframe: 12 months

Number of days from baseline to optimal dose

Timeframe: 12 months

Prescribed daily dose of retigabine at 3, 6, 9, and 12 months

Timeframe: 12 months

Incidence of AEs leading to withdrawal

Timeframe: 12 months

CGI-I score at the end of study

Timeframe: Month 12

Distribution of patient age, gender, race, marital status, and occupation

Timeframe: Month 1

Change in CGI-S score from baseline to the end of study

Timeframe: 12 months

Interventions:
  • Other: Retibabine/ezogabine
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    retigabine
    Collaborators
    Not applicable
    Study date(s)
    August 2014 to August 2016
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Age ≥18 years at date of consent
    • No retigabine therapy prior to date of entry
    • N/A
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Age ≥18 years at date of consent
    • No retigabine therapy prior to date of entry
    • New prescription for retigabine for adjunctive treatment of epilepsy as described in the Summary of Product Characteristics (SmPC)
    Exclusion criteria:
    • N/A

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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