lamotrigine and Cerebral Infarction studies

Cerebral Infarction: The formation of an area of NECROSIS in the CEREBRUM caused by an insufficiency of arterial or venous blood flow. Infarcts of the cerebrum are generally classified by hemisphere (i.e., left vs. right), lobe (e.g., frontal lobe infarction), arterial distribution (e.g., INFARCTION, ANTERIOR CEREBRAL ARTERY), and etiology (e.g., embolic infarction).

Research Excerpts

Excerpt	Relevance	Reference
"To determine the relative tolerability and efficacy of two newer antiepileptic drugs, lamotrigine (LTG) and gabapentin (GBP), as compared to carbamazepine (CBZ) in older patients with epilepsy."	9.11	New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. ( Boardman, KD; Carter, GS; Collins, JF; Felicetta, J; Frederick, T; Marks, W; Pryor, F; Ramsay, RE; Rowan, AJ; Spitz, M; Tomyanovich, ML; Towne, A; Uthman, BM, 2005)
"To determine the relative tolerability and efficacy of two newer antiepileptic drugs, lamotrigine (LTG) and gabapentin (GBP), as compared to carbamazepine (CBZ) in older patients with epilepsy."	5.11	New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. ( Boardman, KD; Carter, GS; Collins, JF; Felicetta, J; Frederick, T; Marks, W; Pryor, F; Ramsay, RE; Rowan, AJ; Spitz, M; Tomyanovich, ML; Towne, A; Uthman, BM, 2005)
"We examined whether the anti-ischemic effect of lamotrigine (LTG), which inhibits the presynapic sodium channel, could be enhanced by the calcium channel blocker-flunarizine (FNR) in cerebral ischemia."	3.70	Neuroprotective effects of lamotrigine enhanced by flunarizine in gerbil global ischemia. ( Lee, YS; Roh, JK; Yoon, BW, 1999)

Research

Studies (4)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment

Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (50.00)	18.2507
2000's	2 (50.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Ataus, SA	1
Onal, MZ	1
Ozdem, SS	1
Locke, KW	1
Balkan, S	1
Rowan, AJ	1
Ramsay, RE	1
Collins, JF	1
Pryor, F	1
Boardman, KD	1
Uthman, BM	1
Spitz, M	1
Frederick, T	1
Towne, A	1
Carter, GS	1
Marks, W	1
Felicetta, J	1
Tomyanovich, ML	1
Smith, SE	1
Meldrum, BS	1
Lee, YS	1
Yoon, BW	1
Roh, JK	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epileps[NCT00438451]	Phase 4	361 participants (Actual)	Interventional	2007-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	proportion of participants (Mean)
Levetiracetam	0.61
Carbamazepine	0.46
Lamotrigine	0.56

Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. (NCT00438451)
Timeframe: week 58

Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)

Intervention	percentage of participants (Number)
Levetiracetam	43
Carbamazepine	33
Lamotrigine	38

Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. (NCT00438451)
Timeframe: Week 30

Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase

Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6

Intervention	percentage of participants (Number)
Levetiracetam	48
Carbamazepine	39
Lamotrigine	49

Intervention	proportion of seizure-free days (Number)
Levetiracetam	0.99
Carbamazepine	0.99
Lamotrigine	0.99

EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45. (NCT00438451)
Timeframe: week 58

The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)

Intervention	units on a scale (Mean)
Levetiracetam	26.0
Carbamazepine	26.0
Lamotrigine	25.4

"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries." (NCT00438451)
Timeframe: over 52 weeks

The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)

Time to Drop Out

Intervention	number of seizures (Number)
Levetiracetam	168
Carbamazepine	131
Lamotrigine	130

Intervention	days (Median)
Levetiracetam	NA
Carbamazepine	NA
Lamotrigine	NA

number of days between randomization and premature discontinuation of the study (NCT00438451)
Timeframe: 58 weeks

Portland Neurotoxicity Scale (PNS) at V6

Intervention	days (Median)
Levetiracetam	NA
Carbamazepine	265
Lamotrigine	NA

"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life." (NCT00438451)
Timeframe: at week 58

QOLIE-31 (Quality Of Life In Epilepsy) Results at V6

Intervention	units on a scale (Mean)
	Cognitive toxicity subscore	Somatomotor subscore	Total Score
Carbamazepine	27.3	11.4	38.7
Lamotrigine	23.7	10.8	34.5
Levetiracetam	22.2	10.5	32.7

The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100. (NCT00438451)
Timeframe: 58 weeks, final visit

Intervention	units on a scale (Mean)
	Seizure worry	Overall quality of life	Emotional well-being	Energy/fatigue	Cognitive functioning	Medication effects	Social functioning	Total Score	Health Scale
Carbamazepine	75.4	65.0	69.8	54.5	68.9	70.6	76.3	68.9	65.7
Lamotrigine	75.0	67.1	67.4	59.8	68.0	72.6	76.7	69.1	67.5
Levetiracetam	85.1	67.2	72.0	60.8	75.1	77.6	81.1	73.9	69.5

"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired" (NCT00438451)
Timeframe: 58 weeks

Intervention	participants (Number)
	Without pathological findings	Borderline	Impaired
Carbamazepine	34	17	33
Lamotrigine	31	15	39
Levetiracetam	38	10	36

"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened" (NCT00438451)
Timeframe: week 58

Article	Year
The effects of citicoline and lamotrigine alone and in combination following permanent middle cerebral artery occlusion in rats. The International journal of neuroscience, 2004, Volume: 114, Issue:2 Topics: Analysis of Variance; Animals; Anticonvulsants; Brain; Brain Ischemia; Cerebral Infarction; Cytidine	2004
Cerebroprotective effect of lamotrigine after focal ischemia in rats. Stroke, 1995, Volume: 26, Issue:1 Topics: Animals; Brain Ischemia; Cerebral Infarction; Drug Administration Schedule; Drug Evaluation, Preclin	1995
Neuroprotective effects of lamotrigine enhanced by flunarizine in gerbil global ischemia. Neuroscience letters, 1999, Apr-23, Volume: 265, Issue:3 Topics: Animals; Brain; Brain Chemistry; Brain Ischemia; Calcium Channel Blockers; Cerebral Infarction; Drug	1999

lamotrigine and Cerebral Infarction