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Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

2014-08-27 03:53:13 | BioPortfolio

Summary

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

LAMICTAL extended-release

Location

GSK Investigational Site
Anniston
Alabama
United States
36207

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:13-0400

Clinical Trials [1455 Associated Clinical Trials listed on BioPortfolio]

Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizure...

Pediatric Epilepsy Study in Subjects 1-24 Months

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have...

Phase 3 Study to Evaluate Efficacy and Safety of Oxcarbazepine Extended-Release in Subjects With Refractory Partial Seizures Due to Epilepsy When Used With up to 3 Other Antiepileptic Drugs.

It is hypothesized that reducing the frequency of dosing may increase subject compliance and providing the drug in an extended-release formulation may alleviate some of the side effects ob...

Lamotrigine Extended-Release In Elderly Patients With Epilepsy

This study is being conducted to determine the safety and tolerability of lamotrigine in elderly patients with epilepsy. This study will be carried out using an extended-release formulatio...

PubMed Articles [6478 Associated PubMed Articles listed on BioPortfolio]

A randomized, double-blind, double-dummy, multicenter trial comparing the efficacy and safety of extended- and immediate-release levetiracetam in people with partial epilepsy.

The aim of this trial was to compare the efficacy and safety of two formulations of levetiracetam in people with partial epilepsy over a 12-week treatment period.

Extended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis.

To compare the estimated glomerular filtration rate (eGFR) at 12 months together with other outcomes among adult kidney transplant recipients (KTRs) who received extended release, once daily tacrolim...

Does extended lesionectomy need to cerebral cavernous malformations presenting with epilepsy? A meta-analysis.

Sought to determine whether extended lesionectomy is needed for cerebral cavernous malformations (CCMs) patients presenting with epilepsy comparing with lesionectomy.

Extended release bupivacaine formulations for postoperative analgesia: an update.

New formulations of local anesthetics with sustained release and longer duration of action are being developed to improve patient outcomes following surgery. This review summarizes the efficacy and sa...

Extended-release drug formulations for the treatment of epilepsy.

Extended-release (ER) preparations are either available or have been tested for several antiepileptic drugs (AEDs). Indeed, they may be helpful in improving efficacy, tolerability, adherence, compared...

Medical and Biotech [MESH] Definitions

Hydrophilic contact lenses worn for an extended period or permanently.

A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)

A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)

An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.

An autosomal dominant inherited partial epilepsy syndrome with onset between age 3 and 13 years. Seizures are characterized by PARESTHESIA and tonic or clonic activity of the lower face associated with drooling and dysarthria. In most cases, affected children are neurologically and developmentally normal. (From Epilepsia 1998 39;Suppl 4:S32-S41)

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