Retrospective analysis of placebo arm data in clinical epilepsy trials

Lead Investigator: Daniel Goldenholz, Beth Israel Deaconess Medical Center
Title of Proposal Research: Retrospective analysis of placebo arm data in clinical epilepsy trials
Vivli Data Request: 5325, 5324
Funding Source: None.
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Epilepsy affects at least 2.2 million Americans, costs $9.5-$12.5 billion annually, and has a 10- fold increased risk of sudden death compared to the general public. Medicines currently do not help 1 out of 3 patients with this disease, and surgery either is ineffective or unavailable to many of these patients. When new medicines are tested in clinical studies, they are compared to placebo. If the medicine is stronger than placebo, then it is considered effective. Clinical studies of epilepsy report a “placebo effect” of 4-19%. Studies in the natural course of epilepsy have found 30-60% of patients that become seizure-free from their disease temporarily or permanently. Recently a simulation using at the largest database of seizures found effects identical to the “placebo effect” without any placebo being given. Taken together, it seems possible that the response to placebo in clinical studies might actually be the natural course of epilepsy, not the placebo effect. Also, it is possible that if we understand this problem better, we may be able to better tell the difference between a “powerful” medicine, and a non-helpful one.

HOW THIS WILL HELP PATIENTS – If the studies can tell the difference between “natural” changes in seizure versus changes from “placebo effects” or medicines, then better medicines can be found faster and for less money

Requested Studies:

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
Sponsor: UCB
Study ID: NCT00783692
Sponsor ID: SP0754

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
Sponsor: 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 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Sponsor: UCB
Study ID: NCT00220415
Sponsor ID: SP0755

A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Pediatric Subjects (4-65 Years) Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic (PGTC) Seizures.
Sponsor: UCB
Study ID: NCT00160550
Sponsor ID: N01057

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.
Sponsor: UCB
Study ID: NCT00490035
Sponsor ID: N01252

An International, Double-blind, Parallel-group, Placebo-controllehttps://doi.org/10.25934/00005133d, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Sponsor: 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
Sponsor: UCB
Study ID: NCT01261325
Sponsor ID: N01358

A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures
Sponsor: GlaxoSmithKline
Study ID: NCT00104416
Sponsor ID: LAM100036

A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures
Sponsor: GlaxoSmithKline
Study ID: NCT00113165
Sponsor ID: LAM100034

A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)
Sponsor: GlaxoSmithKline
Study ID: NCT00043875
Sponsor ID: LAM20006

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
Sponsor: GlaxoSmithKline
Study ID: NCT00232596
Sponsor ID: VRX-RET-E22-301