Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 215 for:    Lamotrigine

BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404168
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : May 15, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
James E Polli, University of Maryland, Baltimore

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Epilepsy
Interventions Drug: lamotrigine (brand Lamictal)
Drug: lamotrigine (generic Teva)
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine Tablet
Hide Arm/Group Description Sequence: generic first, then brand, then brand, and then generic. Each of the four arms will be about two weeks in duration. During the study, subjects will receive their on-going therapeutic lamotrigine regimen of either 200mg, 400mg, or 600mg total daily dosage, divided in twice-a-day doses (i.e. every 12 hours). In the study, 100mg lamotrigine tablets (brand or generic) will be dispensed to the subject at the start of each study arm.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Lamotrigine Tablet
Hide Arm/Group Description Sequence: generic first, then brand, then brand, and then generic
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
48
(22 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  50.0%
White
2
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title AUC
Hide Description pharmacokinetic exposure (ng*hr/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
Time Frame 0-12hr
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator: Lamotrigine Brand Experimental: Lamotrigine Generic
Hide Arm/Group Description:
lamotrigine tablet Lamictal
lamotrigine tablet Teva
Overall Number of Participants Analyzed 4 4
Mean (Standard Error)
Unit of Measure: ng*hr/ml
79640  (11442) 81653  (11991)
2.Primary Outcome
Title Cmax
Hide Description pharmacokinetic rate (ng/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
Time Frame 0-12hr
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator: Lamotrigine Brand Experimental: Lamotrigine Generic
Hide Arm/Group Description:
lamotrigine tablet Lamictal
lamotrigine tablet Teva
Overall Number of Participants Analyzed 4 4
Mean (Standard Error)
Unit of Measure: ng/ml
8836  (1245) 9024  (1203)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator: Lamotrigine Brand Experimental: Lamotrigine Generic
Hide Arm/Group Description lamotrigine tablet Lamictal lamotrigine tablet Teva
All-Cause Mortality
Active Comparator: Lamotrigine Brand Experimental: Lamotrigine Generic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active Comparator: Lamotrigine Brand Experimental: Lamotrigine Generic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Comparator: Lamotrigine Brand Experimental: Lamotrigine Generic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      3/4 (75.00%)    
Nervous system disorders     
headache   1/4 (25.00%)  2 2/4 (50.00%)  2
dizziness   0/4 (0.00%)  0 2/4 (50.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Polli
Organization: University of Maryland
Phone: 410-706-8292
EMail: jpolli@rx.umaryland.edu
Layout table for additonal information
Responsible Party: James E Polli, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02404168     History of Changes
Other Study ID Numbers: HP-00063848
First Submitted: March 17, 2015
First Posted: March 31, 2015
Results First Submitted: April 24, 2019
Results First Posted: May 15, 2019
Last Update Posted: August 19, 2019