lamotrigine and Memory Disorders studies

Memory Disorders: Disturbances in registering an impression, in the retention of an acquired impression, or in the recall of an impression. Memory impairments are associated with DEMENTIA; CRANIOCEREBRAL TRAUMA; ENCEPHALITIS; ALCOHOLISM (see also ALCOHOL AMNESTIC DISORDER); SCHIZOPHRENIA; and other conditions.

Research Excerpts

Excerpt	Relevance	Reference
"The aim of the study was to determine anticonvulsant activity of lamotrigine (LTG) after acute and chronic treatment in four different protocols against maximal electroshock-induced seizures in mice."	7.81	Effects of Chronic Lamotrigine Administration on Maximal Electroshock- Induced Seizures in Mice. ( Banach, M; Borowicz, KK, 2015)
"Status epilepticus was induced by electric stimulation of the perforant pathway (PP) in rats."	5.31	Effect of lamotrigine treatment on status epilepticus-induced neuronal damage and memory impairment in rat. ( Halonen, T; Nissinen, J; Pitkänen, A, 2001)
" Memory alteration was least common with lamotrigine and oxcarbazepine, and there was less association between fatigues with oxcarbazepine/pregabalin."	3.88	Adverse effects of anti-epileptics in trigeminal neuralgiform pain. ( Cregg, R; Lee, G; O'Keeffe, AG; Reading, J; Tentolouris-Piperas, V; Zakrzewska, JM, 2018)
"The aim of the study was to determine anticonvulsant activity of lamotrigine (LTG) after acute and chronic treatment in four different protocols against maximal electroshock-induced seizures in mice."	3.81	Effects of Chronic Lamotrigine Administration on Maximal Electroshock- Induced Seizures in Mice. ( Banach, M; Borowicz, KK, 2015)
"We investigated the impact of repeated seizures on hippocampal memory and amyloid-β (Aβ) load in pre-symptomatic Tg2576 mice, a transgenic model of AD."	1.91	Lamotrigine rescues neuronal alterations and prevents seizure-induced memory decline in an Alzheimer's disease mouse model. ( Curia, G; Giorgi, C; Malerba, F; Marchetti, C; Merenda, E; Middei, S; Paolantoni, C; Pignataro, A; Pimpinella, D; Porcheddu, GF; Rizzello, E; Saviana, M; Titta, G, 2023)
"Status epilepticus was induced by electric stimulation of the perforant pathway (PP) in rats."	1.31	Effect of lamotrigine treatment on status epilepticus-induced neuronal damage and memory impairment in rat. ( Halonen, T; Nissinen, J; Pitkänen, A, 2001)

Research

Studies (10)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	5 (50.00)	29.6817
2010's	4 (40.00)	24.3611
2020's	1 (10.00)	2.80

Authors	Studies
Rizzello, E	1
Pimpinella, D	1
Pignataro, A	1
Titta, G	1
Merenda, E	1
Saviana, M	1
Porcheddu, GF	1
Paolantoni, C	1
Malerba, F	1
Giorgi, C	1
Curia, G	1
Middei, S	1
Marchetti, C	1
Tentolouris-Piperas, V	1
Lee, G	1
Reading, J	1
O'Keeffe, AG	1
Zakrzewska, JM	1
Cregg, R	1
Brown, ES	2
Sayed, N	1
Choi, C	1
Tustison, N	1
Roberts, J	1
Yassa, MA	1
Van Enkevort, E	1
Nakamura, A	1
Ivleva, EI	1
Sunderajan, P	1
Khan, DA	1
Vazquez, M	2
McEwen, B	1
Kulikova, A	1
Frol, AB	1
Holmes, T	1
Cohen, MJ	1
Meador, KJ	3
May, R	1
Loblein, H	1
Conrad, T	1
Baker, GA	1
Bromley, RL	1
Clayton-Smith, J	1
Kalayjian, LA	1
Kanner, A	1
Liporace, JD	1
Pennell, PB	1
Privitera, M	1
Loring, DW	2
Banach, M	1
Borowicz, KK	1
Vahle, VJ	1
Ray, PG	2
Werz, MA	1
Fessler, AJ	1
Ogrocki, P	1
Schoenberg, MR	1
Miller, JM	1
Kustra, RP	1
Smith, ME	1
Gevins, A	1
McEvoy, LK	1
Gilliam, F	1
Wolfshohl, J	1
Shad, MU	1
Osuji, IJ	1
McCabe, PH	1
Eslinger, PJ	1
Halonen, T	1
Nissinen, J	1
Pitkänen, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Does Memantine Improve Verbal Memory Task Performance in Subjects With Localization-related Epilepsy and Memory Dysfunction? A Randomized, Double-Blind, Placebo-Controlled Trial[NCT01054599]		29 participants (Actual)	Interventional	2009-01-31	Completed
Cognitive Effects of Treatment of Interictal Discharges[NCT00916149]		31 participants (Actual)	Interventional	2007-01-31	Completed
A Randomized, Pilot Study to Evaluate the Tolerability of OnabotulinumtoxinA Plus Topiramate vs. OnabotulinumtoxinA Plus Placebo and Long Term Effect of Treatment on Cognitive Efficiency and Continuation of Care[NCT01700387]	Phase 4	20 participants (Actual)	Interventional	2012-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

SRT-CLTR (range 0-72; higher scores indicate better memory), and 7-24 Spatial Memory Test (range 0-35; scores are summed across the 5 learning trials, with higher scores indicating better memory) scores will be assessed across the first (baseline) and third (post-open label memantine) testing sessions. These measures are considered to be scores on a scale, rather than standard units. The hypothesis was that subjects randomized to memantine would demonstrate sustained improvement from baseline, while the placebo group would demonstrate improvements after taking open label memantine (compared to baseline). (NCT01054599)
Timeframe: 26 weeks

The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.

Intervention	scores on a scale (Mean)
	SRT CLTR Baseline	SRT CLTR Post-Open Label	7-24 Total Learning Baseline	7-24 Total Learning Post-Open Label
Memantine	32.67	40.33	30.33	31.67
Sugar Pill	22.71	40.29	28.14	32.43

Change scores from pre- to post-treatment/placebo were calculated for the primary outcome measures, the Selective Reminding Test Continuous Long-Term Retrieval (range 0-72; higher scores indicate better memory) and 7-24 Spatial Recall Test Total Learning (range 0-35; total correct across 5 learning trials are summed, with higher scores indicating better memory) scores. These measures are scores on a scale, rather than representing standard units. (NCT01054599)
Timeframe: 13 weeks

Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment

Intervention	scores on a scale (Mean)
	7-24 Spatial Recall Tests Learning Change Score	SRT Continuous Long-Term Retrieval Change Score
Memantine	1.00	4.38
Sugar Pill	1.78	8.11

This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)

Intervention	IEDs/hour (Mean)
No Treatment	-28.8
Levetiracetam	.54

Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall

Intervention	scores on a scale (Mean)
No Treatment	-1.27
Levetiracetam	1

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning

Intervention	number recalled (Mean)
No Treatment	.36
Levetiracetam	.33

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning

Intervention	number recalled (Mean)
No Treatment	.45
Levetiracetam	.33

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy

Intervention	number recalled (Mean)
No Treatment	1.09
Levetiracetam	.17

Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time

Intervention	percentage of correct responses (Mean)
No Treatment	.02
Levetiracetam	.1

Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy

Intervention	seconds (Mean)
No Treatment	34.96
Levetiracetam	.45

Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)

Intervention	percentage of correct responses (Mean)
No Treatment	-0.01
Levetiracetam	.01

Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay

Intervention	seconds (Mean)
No Treatment	1.04
Levetiracetam	-11.33

Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay

Intervention	number recalled (Mean)
No Treatment	1.55
Levetiracetam	2.67

Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning

Intervention	number recalled (Mean)
No Treatment	1.27
Levetiracetam	-0.4

Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score

Intervention	number recalled (Mean)
No Treatment	8.09
Levetiracetam	5.5

Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency

Intervention	scores on a scale (Mean)
No Treatment	2.45
Levetiracetam	2.5

Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span

Intervention	scores on a scale (Mean)
No Treatment	2.8
Levetiracetam	.83

Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol

Intervention	number recalled (Mean)
No Treatment	.73
Levetiracetam	-.33

Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy

Intervention	scores on a scale (Mean)
No Treatment	3.2
Levetiracetam	1.5

Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time

Intervention	percentage of correct responses (Mean)
No Treatment	.01
Levetiracetam	.03

Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard

Intervention	seconds (Mean)
No Treatment	-66.76
Levetiracetam	.61

Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS

Intervention	seconds (Mean)
No Treatment	-4.73
Levetiracetam	-4.36

Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE

Intervention	scores on a scale (Mean)
No Treatment	.18
Levetiracetam	-0.5

Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy

Intervention	scores on a scale (Mean)
No Treatment	0.18
Levetiracetam	1.5

Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time

Intervention	percentage of correct responses (Mean)
No Treatment	-.01
Levetiracetam	0

Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE

Intervention	seconds (Mean)
No Treatment	-31.99
Levetiracetam	-25.54

Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span

Intervention	scores on a scale (Mean)
Levetiracetam	19.6

Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards. (NCT00916149)
Timeframe: 1 and 11 Weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop

Intervention	number recalled (Mean)
No Treatment	.36
Levetiracetam	-1.67

Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test

Intervention	seconds (Mean)
No Treatment	.98
Levetiracetam	-7.3

Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency

Intervention	seconds (Mean)
No Treatment	-9.51
Levetiracetam	11.29

Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy

Intervention	scores on a scale (Mean)
No Treatment	-1.55
Levetiracetam	-.83

Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time

Intervention	percentage of correct responses (Mean)
No Treatment	.02
Levetiracetam	.14

Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy

Intervention	seconds (Mean)
No Treatment	2.98
Levetiracetam	-6.1

Change in Verbal Working Memory Accuracy Score (range 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time

Intervention	percentage of correct responses (Mean)
No Treatment	0
Levetiracetam	-.02

Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed) (NCT00916149)
Timeframe: 1 and 11 weeks

Number of Non-Serious Adverse Events Between Groups

Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life

Intervention	seconds (Mean)
No Treatment	-54.76
Levetiracetam	-9.36

Intervention	Adverse Events (Mean)
OnabotulinumtoxinA + Topiramate	8.60
OnabotulinumtoxinA + Placebo	4.60

The Headache Impact Test (HIT-6) is a tool used to measure the impact headaches have on an individual's ability to function on the job, at school, at home and in social situations. The HIT-6 score range is from 36 to 78 with higher scores indicating greater impact (worse outcome). (NCT01700387)
Timeframe: Collected on Visit 2 (Day 29), 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)

MEWT Matching to Sample Sub-test Score Percent Change Compared From Baseline to Visits 3-6

Intervention	units on a scale (Mean)
	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	66.50	59.9	60.44	58.71	54.17
OnabotulinumtoxinA + Topiramate	66.40	61.89	54.5	52.83	52.57

The Mental Efficiency Workload Test (MEWT) is a cognitive functioning scale with four sub-scales (Simple Reaction Time, Running Memory Continuous Performance Task, Matching to Sample, and Mathematical Processing). Each sub-scale has a minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. MEWT sub-scale score percent change from baseline will be reported. Positive change scores represent better cognitive functioning compared to baseline. (NCT01700387)
Timeframe: Baseline, Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)

MEWT Mathematical Processing Sub-test Score Percent Change Compared From Baseline to Visits 3-6

Intervention	percentage of change from baseline score (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	21.74	8.59	12.72	24.75
OnabotulinumtoxinA + Topiramate	19.06	15.04	18.49	40.86

MEWT Running Memory Continuous Performance Task Sub-test Score Percent Change Compared From Baseline to Visits 3-6

Intervention	percentage of change from baseline score (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	17.74	16.43	28.61	29.44
OnabotulinumtoxinA + Topiramate	-11.23	-22.90	-23.81	1.52

MEWT Simple Reaction Time Sub-test Score Percent Change Compared From Baseline to Visits 3-6

Intervention	percentage of change from baseline score (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	1.13	4.39	18.81	2.2
OnabotulinumtoxinA + Topiramate	-15.66	-1.20	-3.96	-6.99

Number of Headache Days

Intervention	percentage of change from baseline score (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	14.22	4.76	-4.17	2.31
OnabotulinumtoxinA + Topiramate	-8.90	-3.20	-3.87	-3.16

Number of Headache Days reported in 30-day Baseline Period and Treatment Period Months 1-12 (NCT01700387)
Timeframe: Baseline and Months 1-12

Physician Global Impression of Change (PGIC)

Intervention	Headache days (Mean)
	Baseline	Month 1	Month 2	Month 3	Month 4	Month 5	Month 6	Month 7	Month 8	Month 9	Month 10	Month 11	Month 12
OnabotulinumtoxinA + Placebo	23.77	21.67	17.54	18.37	14.39	13.47	16.58	12.54	11.5	9.96	8.02	8.51	8.06
OnabotulinumtoxinA + Topiramate	22.95	18.41	16.50	16.83	15.74	11.34	15.18	12.64	12.36	12.02	6.93	8.36	7.51

Score on Physician Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better. (NCT01700387)
Timeframe: Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)

Subject Attrition Post Randomization

Intervention	units on a scale (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	5.30	5.89	5.83	5.83
OnabotulinumtoxinA + Topiramate	5.25	5.40	6.67	6.83

Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up) (NCT01700387)
Timeframe: Collected on Visit 2 (Day 29) through Visit 6 (Day 365)

Subject Estimation of Compliance With Daily Study Drug

Intervention	participants (Number)
	Consent Withdrawn	Withdrawn Due to Adverse Event	Lost to Follow Up
OnabotulinumtoxinA + Placebo	2	1	1
OnabotulinumtoxinA + Topiramate	1	1	2

Subject estimation of compliance with daily study drug during the study period. Compliance ranges from 0% to 100% with higher percentages indicating greater compliance with study drug. (NCT01700387)
Timeframe: Collected on Visit 2 (Day 29), 3 (Day 113), Visit 4 (Day 197), and Visit 5 (281)

Subject Global Impression of Change (SGIC)

Intervention	percentage of compliance (Mean)
	Visit 2	Visit 3	Visit 4	Visit 5
OnabotulinumtoxinA + Placebo	99.73	99.73	97.65	99.63
OnabotulinumtoxinA + Topiramate	100	99.84	99.55	98.69

Score on Subject Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better. (NCT01700387)
Timeframe: Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)

Subject's Controlled Oral Word Association Test (COWAT) Score Percent Change Compared From Baseline to Visits 3-6

Intervention	units on a scale (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	5.30	5.77	6.17	6.00
OnabotulinumtoxinA + Topiramate	5.38	6.33	6.66	7.00

The Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency. Raw COWAT scores have a lower bound of 0 with no upper bound. Higher scores indicate better verbal fluency. COWAT score percent change from baseline will be reported. Positive change scores represent better verbal fluency compared to baseline. (NCT01700387)
Timeframe: Baseline, Visit 3 (Day 113) through Visit 6 (Day 365)

Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life

Intervention	percentage of change from baseline score (Mean)
	Visit 3	Visit 4	Visit 5	Visit 6
OnabotulinumtoxinA + Placebo	-3.50	-8.93	1.48	-4.99
OnabotulinumtoxinA + Topiramate	-17.06	-17.93	-12.63	-5.05

The Migraine-Specific Quality of Life Questionnaire (MSQ) is a scale that measures the impact of migraine across three aspects: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Possible scores on each sub-scale range from a 0 to 100 scale such that higher scores indicate better quality of life. (NCT01700387)
Timeframe: Baseline, Months: 3, 6, 9 and 12

Intervention	score on a scale (Mean)
	Role Function-Restrictive - Baseline	Role Function-Restrictive - Month 3	Role Function-Restrictive - Month 6	Role Function-Restrictive - Month 9	Role Function-Restrictive - Month 12	Role Function-Preventive - Baseline	Role Function-Preventive - Month 3	Role Function-Preventive - Month 6	Role Function-Preventive - Month 9	Role Function-Preventive - Month 12	Emotional Function - Baseline	Emotional Function - Month 3	Emotional Function - Month 6	Emotional Function - Month 9	Emotional Function - Month 12
OnabotulinumtoxinA + Placebo	29.71	56.29	59.37	60.41	72.38	46.50	65.00	72.22	72.86	80.83	22.67	56.67	56.30	70.48	78.89
OnabotulinumtoxinA + Topiramate	32.14	56.51	77.14	79.52	81.90	56.50	72.78	90.00	88.33	96.67	39.33	57.78	88.89	92.22	95.56

Article	Year
A randomized, double-blind, placebo-controlled trial of lamotrigine for prescription corticosteroid effects on the human hippocampus. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology, 2019, Volume: 29, Issue:3 Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Antipsychotic Agents; Double-Blind Method; Female;	2019
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology, 2005, Jun-28, Volume: 64, Issue:12 Topics: Adult; Anticonvulsants; Brain; Cognition Disorders; Cross-Over Studies; Dose-Response Relationship,	2005
Distinct cognitive neurophysiologic profiles for lamotrigine and topiramate. Epilepsia, 2006, Volume: 47, Issue:4 Topics: Adult; Anticonvulsants; Cognition; Cognition Disorders; Cortical Synchronization; Cross-Over Studies	2006
Attenuation of the effects of corticosteroids on declarative memory with lamotrigine. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2008, Volume: 33, Issue:10 Topics: Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Atrophy; Double-Blind Method; Drug Synergi	2008

Article	Year
Lamotrigine rescues neuronal alterations and prevents seizure-induced memory decline in an Alzheimer's disease mouse model. Neurobiology of disease, 2023, 06-01, Volume: 181 Topics: Alzheimer Disease; Amyloid beta-Peptides; Animals; Anticonvulsants; Disease Models, Animal; Hippocam	2023
Adverse effects of anti-epileptics in trigeminal neuralgiform pain. Acta neurologica Scandinavica, 2018, Volume: 137, Issue:6 Topics: Adult; Aged; Anticonvulsants; Carbamazepine; Cross-Sectional Studies; Fatigue; Female; Humans; Lamot	2018
Fetal antiepileptic drug exposure and learning and memory functioning at 6 years of age: The NEAD prospective observational study. Epilepsy & behavior : E&B, 2019, Volume: 92 Topics: Adult; Anticonvulsants; Carbamazepine; Child; Epilepsy; Female; Humans; Lamotrigine; Learning; Memor	2019
Effects of Chronic Lamotrigine Administration on Maximal Electroshock- Induced Seizures in Mice. CNS & neurological disorders drug targets, 2015, Volume: 14, Issue:7 Topics: Animals; Anticonvulsants; Avoidance Learning; Blood Chemical Analysis; Brain; Chromatography, High P	2015
Abnormal Wada and neuropsychological testing results due to topiramate therapy. Epilepsia, 2000, Volume: 41, Issue:7 Topics: Amobarbital; Anticonvulsants; Carbamazepine; Carotid Artery, Internal; Drug Therapy, Combination; Ep	2000
Effect of lamotrigine treatment on status epilepticus-induced neuronal damage and memory impairment in rat. Epilepsy research, 2001, Volume: 46, Issue:3 Topics: Animals; Anticonvulsants; Body Temperature; Body Weight; Brain; Lamotrigine; Male; Memory Disorders;	2001

lamotrigine and Memory Disorders