Lead Investigator: Emma Fröling, Universitätsmedizin Charité Berlin
Title of Proposal Research: Systematic Review and Meta-Analysis of Adverse Events During Levetiracetam Therapy
Vivli Data Request: 9809
Funding Source: None
Potential Conflicts of Interest: I am currently employed at Pfizer Pharma GmbH. However, I want to emphasize that my research activities as a doctoral student in medical sciences at Universitätsmedizin Charité Berlin are conducted independently of my employment at Pfizer Pharma GmbH. I declare that there are no conflicts of interest related to the requested data arising from this dual affiliation.
To clarify why a potential conflict of interest is unlikely, I pursued a research topic that is unrelated to my current professional work in the pharmaceutical industry, specifically in Infectious Diseases.
My doctoral degree contract stipulates that data processing, analysis, and interpretation must be conducted impartially and free from any professional influences.
Furthermore, the data interpretation at the group level will be independently reviewed by my supervisor, who has no affiliations with the industry.
Should any conflicts of interest arise during my research, I will disclose them promptly.
Summary of the Proposed Research:
Epilepsy is a condition where a person experiences recurring seizures, which are like sudden electrical storms in the brain. These seizures can affect a person’s consciousness, movements, or sensations. It’s quite common, with millions of people around the world dealing with epilepsy. This research is digging into a key drug, Levetiracetam, which helps in managing these seizures. We have selected levetiracetam for an in-depth analysis, as it has been an essential therapy for epilepsy in medical practice for nearly 25 years. This milestone presents a valuable opportunity to review and assess the current evidence on its side effects, thereby contributing to improved clinical decision-making.
Imagine it as a sort of guardian that helps keep these brain storms under control. It’s used for both grown-ups and kids, either by itself or with other treatments. This medicine doesn’t cure epilepsy, but it does a great job in keeping those electrical storms in the brain at bay. Think of it as a shield that helps people with epilepsy live more comfortably. “Adverse events” are basically unexpected or unwanted side effects which can occur, like when a medicine causes something you didn’t want to happen. We want to understand if Levetiracetam might affect how people think or feel in unwanted ways. We’re gathering information about these adverse events to understand if these are really related to Levetiracetam or other circumstances. To do that we compare people taking Levetiracetam and people who don’t. Furthermore, we analyze if the occurence of adverse events is dependent on different factors like person’s age, the Levetiracetam dosage or why it’s prescribed.
All appropriate studies will be incorporated into the main analysis. However, certain analyses may exclude some studies, particularly those with a high risk of bias, so that we are including the ones that can best help us understand how Levetiracetam works and its effects on people. Using systematic review and meta-analysis – powerful methods that help us gather the most accurate and helpful information. These methods ensure we don’t miss any crucial details, allowing the puzzle pieces to come together and provide us with a complete picture of Levetiracetam’s impact on epilepsy treatment.
Requested Studies:
A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures
Data Contributor: UCB
Study ID: NCT00150735
Sponsor ID: N01061
A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Data Contributor: UCB
Study ID: NCT01498822
Sponsor ID: N01367
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.
Data Contributor: UCB
Study ID: NCT00160550
Sponsor ID: N01057
A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT00419094
Sponsor ID: N01280
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
An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
Data Contributor: UCB
Study ID: NCT00419393
Sponsor ID: N01281
An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures
Data Contributor: UCB
Study ID: NCT01506882
Sponsor ID: N01375
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures
Data Contributor: UCB
Study ID: NCT01228747
Sponsor ID: N01159
An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures
Data Contributor: UCB
Study ID: NCT01954121
Sponsor ID: N01364