Full Text View
Tabular View
Study Results
Related Studies
Lamotrigine Extended-Release In Elderly Patients With Epilepsy
This study has been completed.
Study NCT00516139   Information provided by GlaxoSmithKline

First Received on August 13, 2007.   Last Updated on December 8, 2011   History of Changes
Results First Received: July 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: Lamotrigine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of 4 phases (Ph): 7-week (w) Dose-escalation Ph, 8-w Adjunctive Maintenance (AM) Ph, 13-w Adj. Optimization (AO) Ph or 13-w Conversion/Monotherapy (C/M) Ph, and a 2-5 w Taper/Follow up (T/F) Ph.

Reporting Groups
  Description
Lamotrigine (LTG)-Extended Release (XR) Tablets LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.

Participant Flow:   Overall Study
    Lamotrigine (LTG)-Extended Release (XR) Tablets  
STARTED     122  
COMPLETED     84 [1]
NOT COMPLETED     38  
Adverse Event                 27  
Lost to Follow-up                 1  
Protocol Violation                 1  
Withdrawal by Subject                 8  
Lack of Efficacy                 1  
[1] Study completers completed Escalation, AM, and either AO or both Conversion and Monotherapy Phases.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
LTG-XR Tablets LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.

Baseline Measures
    LTG-XR Tablets  
Number of Participants  
[units: participants]
 		  121  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  72.5  ± 5.53  
Gender [1]
[units: Participants]
 		 
Female     59  
Male     62  
Race/Ethnicity, Customized [2]
[units: participants]
 		 
African American/African Heritage     14  
Asian - South East Asian Heritage     2  
White - Arabic/North African Heritage     1  
White - White/Caucasian/European Heritage     105  
[1] Baseline characteristics were collected for the Safety Population, which included all participants who were enrolled and took at least one dose of the study drug. One participant enrolled in the study did not take at least one dose of the study drug.
[2] Baseline characteristics were collected for the Safety Population, which included all participants who were enrolled and took at least one dose of the study drug. One participant enrolled in the study did not take at least one dose of the study drug. Participants are allowed to select more than one race.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event   [ Time Frame: From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33) ]
  Show Outcome Measure 1

2.  Secondary:   Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study   [ Time Frame: Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study   [ Time Frame: Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period   [ Time Frame: Week 30 or 33 ]
  Show Outcome Measure 4

5.  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   [ Time Frame: Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD]) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale   [ Time Frame: Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD]) ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS]) ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in the Height at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS]) ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in the Weight at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS]) ]
  Show Outcome Measure 9

10.  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   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 10

11.  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   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 15

16.  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   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 17

18.  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   [ Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD) ]
  Show Outcome Measure 18

19.  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   [ Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28 ]
  Show Outcome Measure 19

20.  Secondary:   Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA   [ Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28 ]
  Show Outcome Measure 20

21.  Secondary:   Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA   [ Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28 ]
  Show Outcome Measure 21

22.  Secondary:   Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA   [ Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28 ]
  Show Outcome Measure 22


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00516139     History of Changes
Other Study ID Numbers: LEP105972
Study First Received: August 13, 2007
Results First Received: July 15, 2011
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services