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

A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113165

Enrollment

244

Registered

2005-06-07

Start date

2004-10-31

Completion date

2007-07-31

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Epilepsy, Partial

Keywords

partial seizures, Epilepsy, antiepileptic drugs, anticonvulsants, LAMICTAL, seizures, lamotrigine

Brief 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.

Interventions

DRUGLAMICTAL extended-release

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of epilepsy with partial seizures for more than 24 weeks. * Must experience at least 8 partial seizures during an 8-week Baseline Phase. * Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks. * Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion criteria

* Previous treatment with lamotrigine. * Exhibits any primary generalized seizures. * Receiving treatment with felbamate or currently following the ketogenic diet. * Pregnant, breastfeeding, or planning to become pregnant.

Design outcomes

Primary

Measure	Time frame
The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.	24 Weeks

Secondary

Measure	Time frame
Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics	24 Weeks

Countries

Argentina, Brazil, Chile, Germany, India, Puerto Rico, Russia, South Korea, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026