Last updated: 11/07/2018 09:33:17

Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304

GSK study ID
115476
See study documents
Clinicaltrials.gov ID
NCT01457989
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Meta-Analysis of VRX-RET-E22-303 and VRX-RET-E22-304: Two Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Studies of Retigabine in Adult Epilepsy Patients with Partial-onset Seizures (Extensions of Studies VRX-RET-E22-301 and VRX-RET-E22-302)
Trial description: The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing open-label extension (OLE) Studies VRX-RET-E22-303 and VRX-RET-E22-304.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of Adverse Events

Timeframe: during open-label drug exposure up to database cutoff (max 40 months)

Secondary outcomes:

Time to Discontinuation

Timeframe: during open-label extension up to date of discontinuation; subjects who continue in the study are censored at database cutoff (max 40 months)

The number and percent of subjects exposed to study drug

Timeframe: for at least 3, 6, 12, 18, 24 and 32 months

Listing of abnormal liver function test results and liver adverse events

Timeframe: during open-label drug exposure up to database cutoff (max 40 months)

Observed values and change from baseline summaries for American Urological Association symptom index scores, Post-Void Residual bladder ultrasound, Vital Signs and Weight

Timeframe: baseline (parent study) and at 1, 3, 12, 24 and 36 months

Percent change from baseline in seizure frequency

Timeframe: entire open-label extension period up to database cutoff (max 40 months)

Number and percent of responders

Timeframe: entire open-label extension period up to database cutoff (max 40 months)

Number and percent of seizure free subjects

Timeframe: during open-label drug exposure up to database cutoff (max 40 months)

Proportion of subjects retained in the study

Timeframe: at 3, 6, 12, 24 and 32 months after exposure to first dose in open-label extension study.

Mean of average dose

Timeframe: entire open-label drug extension period up to database cutoff (max 40 months)

Interventions:
  • Drug: retigabine/ezogabine
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Antonio Gil-Nagel, Martin J Brodie, Robert Leroy, Tracy Cyr, Susan Hall, Mary Castiglia, Colleen Twomey, Kevan VanLandingham. Safety and Efficacy of Ezogabine (Retigabine) in Adults with Refractory Partial-Onset Seizures: Interim Results from Two Ongoing Open-Label Studies. Epilepsy Res. 2012;102:117-121.
    Medical condition
    Epilepsy, Partial
    Product
    retigabine
    Collaborators
    Not applicable
    Study date(s)
    August 2011 to September 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    No
    • This is meta-analysis therefore Inclusion/Exclusion criteria are not applicable.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • This is meta-analysis therefore Inclusion/Exclusion criteria are not applicable.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-30-09

    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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