Trial Outcomes & Findings for BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients (NCT NCT02404168)

Last Updated: 2019-08-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

0-12hr

Results posted on

2019-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Lamotrigine Tablet 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lamotrigine Tablet n=4 Participants Sequence: generic first, then brand, then brand, and then generic
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-12hr

Outcome measures

Outcome measures
Measure	Active Comparator: Lamotrigine Brand n=4 Participants lamotrigine tablet Lamictal	Experimental: Lamotrigine Generic n=4 Participants lamotrigine tablet Teva
AUC	79640 ng*hr/ml Standard Error 11442	81653 ng*hr/ml Standard Error 11991

PRIMARY outcome

Timeframe: 0-12hr

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.

Outcome measures

Outcome measures
Measure	Active Comparator: Lamotrigine Brand n=4 Participants lamotrigine tablet Lamictal	Experimental: Lamotrigine Generic n=4 Participants lamotrigine tablet Teva
Cmax	8836 ng/ml Standard Error 1245	9024 ng/ml Standard Error 1203

Adverse Events

Active Comparator: Lamotrigine Brand

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Experimental: Lamotrigine Generic

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Comparator: Lamotrigine Brand n=4 participants at risk lamotrigine tablet Lamictal	Experimental: Lamotrigine Generic n=4 participants at risk lamotrigine tablet Teva
Nervous system disorders headache	25.0% 1/4 • Number of events 2	50.0% 2/4 • Number of events 2
Nervous system disorders dizziness	0.00% 0/4	50.0% 2/4 • Number of events 2

Additional Information

James Polli

University of Maryland

Phone: 410-706-8292

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place