Phase 3 N=122 Treatment

Lamotrigine Extended-Release In Elderly Patients With Epilepsy

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT00516139 ↗

Enrolled (actual)

122

Serious AEs

18.2%

Results posted

Jan 2012

Primary outcome: Primary: Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event — 22; 112 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lamotrigine (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event	22; 112	—
SECONDARY Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study	97.8; 100.0; 100.0; 100.0; 100.0; 90.4	—
SECONDARY Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study	49; 41; 30; 27; 2; 39	—
SECONDARY Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period	53; 13	—
SECONDARY Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale	36; 54; 1; 13; 7; 1	—
SECONDARY Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale	51; 29; 11; 17; 2; 2	—
SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study	1.51; -0.62; 0.68; -4.00; -2.19; -1.22	—
SECONDARY Change From Baseline in the Height at the Indicated Time Points in the Study	0.03; 0.29; -0.03; -0.03; 0.03	—
SECONDARY Change From Baseline in the Weight at the Indicated Time Points in the Study	-0.22; -0.41; -0.48; -0.27; -0.41	—
SECONDARY Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study	0.00; 0.00; 0.00; 0.00; 0.00; 0.01	—
SECONDARY Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study	0.00; 0.00; 0.00; 0.00; 0.20; 0.10	—
SECONDARY Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study	-4.00; 1.00; -5.00; 1.00; 0.00; -1.00	—
SECONDARY Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study	-0.10; 0.10; -0.20; -0.20	—
SECONDARY Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study	0.00; -1.00; 1.00; 0.00	—
SECONDARY Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study	-0.10; -0.20; -0.10; 0.00	—
SECONDARY Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study	1.00; -0.50; -5.0; 2.00; -2.00; -1.0	—
SECONDARY Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points	-0.1; -0.1; -0.3; -0.1; 0.1; -0.0	—
SECONDARY Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA	NA; NA; 0.957; NA; NA; 1.362	—
SECONDARY Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA	1.91; 2.07; -0.698	—
SECONDARY Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA	26.8	—
SECONDARY Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA	0.0325	—

Summary

This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

Eligibility Criteria

Inclusion criteria

Confident diagnosis of epilepsy
Currently treated with one or two antiepileptic medications
Able to complete a seizure diary

Exclusion criteria

History of hypersensitivity to lamotrigine
Progressive diseases that would interfere with the study objectives

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00516139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.