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Epilepsy, PartialNCT01457989

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

An observational study of Epilepsy, Partial, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Epilepsy, Partial
What is being tested?
retigabine/ezogabine
How many people
1 participants
Where
No sites listed yet
Study dates
Aug 2011to Aug 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with partial onset seizures who have successfully completed the transition phase of VRX-RET-E22-301 and VRX-RET-E22-302.

This is meta-analysis therefore Inclusion/Exclusion criteria are not applicable.

About this study

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)

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.

Read the detailed description

Data from the October 2009 data-cut of ongoing Studies VRX-RET-E22-303 (Study 303) and VRX-RET-E22-304 (Study 304) will be pooled, summarized, and published with the goal of providing updated long-term safety and efficacy information for subjects and prescribers following the recent positive CHMP opinion for retigabine for adjunctive use in patients with partial seizures. Studies 303 and 304 are the open-label extensions of two Phase 3 studies (VRX-RET-E22-301 and VRX-RET-E22-302), respectively. Studies 301 and 302 were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies of 600 mg and 900 mg per day (Study 302) and 1200 mg per day (Study 301). All subjects who wished to enter the OLE studies and, in the opinion of the investigator, were expected to benefit from participation in the OLEs, entered a 6-week (Study 301) or 4-week (Study 302) transition phase in which their dose of retigabine was titrated to or maintained at 400 mg TID (Study 301) or 300 mg TID (Study 302). Upon completion of the Transition phase, subjects enrolled into the extension studies. Once enrolled in the OLE, doses could be adjusted within the range of 600 mg to 1200 mg per day. Treatment in Studies 303 and 304 is planned to continue until regulatory approval and commercialization of retigabine or until the program is discontinued.

Being tested
retigabine/ezogabine
Keywords
retention rate, epilepsy, responder rate, seizure freedom, discontinuation rate, safety assessment, reduction in seizure frequency, open-label
Medical subject headings
Epilepsies, Partial, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • retigabine/ezogabineDrug

    Also called Trobalt

    dose range up to 1200 mg/day

Study groups in NCT01457989
Study groupRoleWhat they receive
retigabine/ezogabineretigabine/ezogabine; dose range up to 1200 mg/day
Receives: Drug: retigabine/ezogabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events

    Adverse events were the primary means to assess safety.

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

Secondary outcomes (9)

  1. Time to Discontinuation

    Time to discontinuation in number of days since first dose in open-label extension until subject discontinues

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

  2. The number and percent of subjects exposed to study drug

    The number and percent of subjects exposed to study drug

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

  3. Listing of abnormal liver function test results and liver adverse events

    Abnormal lab results if reported as adverse events or values of alkaline phosphatase, alanine transaminase, aspartate transaminase [>3, >5, >10xupper limit of normal (ULN)] or total bilirubin (>1.5, >2, >4xULN); treatment emergent adverse events related to liver function test abnormalities

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

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

    Univariate statistics summarizing the observed values and change from baseline, using parent study baseline value

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

  5. Percent change from baseline in seizure frequency

    Percent change from baseline in 28-day total partial seizure frequency, using parent study baseline value.

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

  6. Number and percent of responders

    Number and percent of responders (defined as subjects with >=50% reduction from baseline in 28-day total partial seizure frequency) using parent study baseline value

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

  7. Number and percent of seizure free subjects

    Percent of subjects seizure free for any 6 continuous months or longer for subjects treated for at least 6, 12 and 24 months; percent of seizure free subjects for any 12 continuous months or longer for subjects treated for at least 12 and 24 months

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

  8. Proportion of subjects retained in the study

    Length of time subjects retained in OLE as summarized by proportion of subjects remaining in both studies at given timepoints.

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

  9. Mean of average dose

    Mean average dose for all subjects combined and by modal dose category [the range of doses (<=750 mg/day, >750 to 1050 mg/day, >1050 mg/day) taken most frequently].

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01457989
Sponsor's protocol ID
115476
Status last verified
Oct 2012
First submitted
20 Oct 2011
Last updated
29 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, Partial, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: during open-label drug exposure up to database cutoff (max 40 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01457989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.

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