Lead Investigator: Catrin Tudur-Smith, University of Liverpool
Title of Proposal Research: Add-on treatment for refractory focal-onset epilepsy: Individual Participant Data Network Meta-analysis
Vivli Data Request: 7227
Funding Source: The Liverpool Reviews and Implementation Group, a University-based non-commercial academic centre, as part of its capacity development funding from the UK National Institute for Health Research.
Potential Conflicts of Interest: A consortium of pharmaceutical companies (GSK, EISAI, UCB Pharma) funded the National Audit of Seizure Management in Hospitals (NASH) through grants paid to the University of Liverpool. Professor Tony Marson is part funded by National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care North West Coast (NIHR CLAHRC NWC).
Funding received by Professor Tony Marson and by the NASH study are declared for transparency and are unrelated to the proposed research.
Summary of the Proposed Research:
Epilepsy is a common neurological condition, with an estimated incidence of 49 per 100,000 and prevalence of 4 to 10 per 1000 in the developed world . Between two and three per cent of the population will be given a diagnosis of epilepsy at some time in their lives, the majority of whom will go into remission. However, up to 30% will fail to respond to monotherapy, often requiring treatment with combinations of antiepileptic drugs (AEDs) . These individuals will often experience significant adverse psychological and quality of life outcomes, due to continued and unpredictable seizures, side effects of drugs, and reduced educational and employment prospects.
This is a systematic review and individual participant data (IPD) network meta-analysis (NMA) of randomised controlled trials of add-on treatment for patients with refractory focal-onset epilepsy uncontrolled by one or more concomitant AEDs. In the majority of these trials, patients are randomised to have either active AED or placebo added to their existing AED treatment. This is in keeping with international guidelines on the development of AEDs . Once a drug has confirmed efficacy and safety as an add‐on therapy, it is usually then tested as monotherapy and in other epilepsy syndromes. An IPD NMA of AEDs taken as monotherapy is the subject of a separate Cochrane review .
Requested Studies:
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT00464269
Sponsor ID: N01253
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT01261325
Sponsor ID: N01358
A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Data Contributor: UCB
Study ID: NCT00490035
Sponsor ID: N01252
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/day, 400mg/day, 600mg/day) as Adjunctive Therapy in Subjects with Partial Seizures with or without Secondary Generalization
Data Contributor: UCB
Study ID: SP0667
Sponsor ID: SP0667
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Data Contributor: UCB
Study ID: NCT00136019
Sponsor ID: SP0754
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Data Contributor: UCB
Study ID: NCT00220415
Sponsor ID: SP0755
A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients
Data Contributor: GSK
Study ID: 105-040
Sponsor ID: 105-040
A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures
Data Contributor: GSK
Study ID: NCT00113165
Sponsor ID: LAM100034
An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)
Data Contributor: GSK
Study ID: NCT00044278
Sponsor ID: LAM20007
Double-Blind Parallel Comparison of Topiramate 400 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
Data Contributor: Johnson & Johnson
Study ID: NCT00236860
Sponsor ID: CR005569
A double-blind, randomized trial of topiramate as adjunctive therapy for partial-onset seizures in children
Data Contributor: Johnson & Johnson
Study ID: YP
Sponsor ID: YP
Double-Blind Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy
Data Contributor: Johnson & Johnson
Study ID: NCT00236730
Sponsor ID: CR005458
Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
Data Contributor: Johnson & Johnson
Study ID: NCT00236873
Sponsor ID: CR005563
Double-Blind, Parallel Comparison of Topiramate 300 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
Data Contributor: Johnson & Johnson
Study ID: NCT00236847
Sponsor ID: CR005566
An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
Data Contributor: UCB
Study ID: NCT00504881
Sponsor ID: N01254
A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Years of Age With Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT01921205
Sponsor ID: SP0969
A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT01229735
Sponsor ID: N01353
A Multicenter, Placebo-Controlled, Parallel-Design, Dose-Response Evaluation of the Safety and Efficacy of Lamotrigine as Add-On Therapy in Epileptic Outpatients with Partial Seizures
Data Contributor: GSK
Study ID: P42-05
Sponsor ID: P42-05
A Multicenter, Double-Blind, Placebo-Controlled, Add-On, Crossover Study of Lamotrigine in Epileptic Outpatients with Partial Seizures
Data Contributor: GSK
Study ID: P42-06
Sponsor ID: P42-06
A Multicenter, Placebo-Controlled Parallel-Design, Phase III Evaluation of the Safety of Lamotrigine (LAMICTAL) as Add-On Therapy in Outpatients with Partial Seizures
Data Contributor: GSK
Study ID: P42-16
Sponsor ID: P42-16