Page last updated: 2024-10-30
lamotrigine and Asthenia
lamotrigine has been researched along with Asthenia in 1 studies
Asthenia: Clinical sign or symptom manifested as debility, or lack or loss of strength and energy.
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy." | 9.10 | Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002) |
| "This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy." | 5.10 | Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002) |
Research
Studies (1)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 1 (100.00) | 29.6817 |
| 2010's | 0 (0.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Brodie, MJ | 1 |
| Chadwick, DW | 1 |
| Anhut, H | 1 |
| Otte, A | 1 |
| Messmer, SL | 1 |
| Maton, S | 1 |
| Sauermann, W | 1 |
| Murray, G | 1 |
| Garofalo, EA | 1 |
Clinical Trials (1)
Trial Overview
| 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] |
Trial Outcomes
58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment
(NCT00438451)
Timeframe: 58 weeks
| Intervention | proportion of participants (Mean) |
|---|
| Levetiracetam | 0.61 |
| Carbamazepine | 0.46 |
| Lamotrigine | 0.56 |
Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)
Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. (NCT00438451)
Timeframe: week 58
| Intervention | percentage of participants (Number) |
|---|
| Levetiracetam | 43 |
| Carbamazepine | 33 |
| Lamotrigine | 38 |
Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)
Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. (NCT00438451)
Timeframe: Week 30
| Intervention | percentage of participants (Number) |
|---|
| Levetiracetam | 48 |
| Carbamazepine | 39 |
| Lamotrigine | 49 |
Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase
(NCT00438451)
Timeframe: 52 weeks
| Intervention | proportion of seizure-free days (Number) |
|---|
| Levetiracetam | 0.99 |
| Carbamazepine | 0.99 |
| Lamotrigine | 0.99 |
Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6
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
| Intervention | units on a scale (Mean) |
|---|
| Levetiracetam | 26.0 |
| Carbamazepine | 26.0 |
| Lamotrigine | 25.4 |
The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)
"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
| Intervention | number of seizures (Number) |
|---|
| Levetiracetam | 168 |
| Carbamazepine | 131 |
| Lamotrigine | 130 |
The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)
(NCT00438451)
Timeframe: over the whole duration of 58 weeks
| Intervention | days (Median) |
|---|
| Levetiracetam | NA |
| Carbamazepine | NA |
| Lamotrigine | NA |
Time to Drop Out
number of days between randomization and premature discontinuation of the study (NCT00438451)
Timeframe: 58 weeks
| Intervention | days (Median) |
|---|
| Levetiracetam | NA |
| Carbamazepine | 265 |
| Lamotrigine | NA |
Portland Neurotoxicity Scale (PNS) at V6
"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
| 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 |
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
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 |
Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6
"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 |
Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)
"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
| Intervention | participants (Number) |
|---|
| Improved | Unchanged | Worsened |
|---|
| Carbamazepine | 16 | 56 | 8 |
,| Lamotrigine | 15 | 53 | 13 |
,| Levetiracetam | 15 | 61 | 6 |
Trials
1 trial available for lamotrigine and Asthenia