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
Cancelled
Cancelled
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Cancelled
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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