Clinical Evaluation of BW430C in Epilepsy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-07

Study Completion Date

2009-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

NCT01832038

Epilepsy Partial-onset Seizures

COMPLETED PHASE3

Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study

NCT02100644

Epilepsy

COMPLETED PHASE4

A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures

NCT02124564

Epilepsy Partial-onset Seizures

COMPLETED PHASE3

Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy

NCT01431963

Epilepsy

COMPLETED PHASE3

Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

NCT00866775

Epilepsy With Simple or Complex Partial Onset Seizures

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lamictal

Group Type EXPERIMENTAL

lamictal

Intervention Type DRUG

anti-epileptic drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lamictal

anti-epileptic drug

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Epilepsy with partial seizures
* Tonic clonic seizures
* Generalized seizures of Lennox-Gastaut
* Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.
* Concurrent AEDs: Subjects taking concurrent VPA.

Exclusion Criteria

* Previous participation in a study of Lamictal
* Known hypersensitivity to any drugs
* Pregnant women
* nursing mothers
* women who may be pregnant
* women contemplating pregnancy during the study period

Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No