lamotrigine has been researched along with Fatigue in 8 studies
Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.
Excerpt | Relevance | Reference |
---|---|---|
"The objective was to assess the efficacy and safety of adjunctive brivaracetam (BRV) with concomitant use of lamotrigine (LTG) or topiramate (TPM) in patients with uncontrolled focal seizures." | 5.27 | Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. ( Benbadis, S; Diaz, A; Elmoufti, S; Klein, P; Schiemann, J; Whitesides, J, 2018) |
"To determine the effects of lamotrigine on (1) seizures, (2) adverse-effect profile, and (3) cognition and quality of life, compared to placebo, when used as an add-on treatment for people with drug-resistant focal epilepsy." | 5.05 | Lamotrigine add-on therapy for drug-resistant focal epilepsy. ( Bresnahan, R; Marson, AG; Panebianco, M; Ramaratnam, S, 2020) |
" 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) |
"Levetiracetam was independently associated with anger/aggression, nervousness/agitation, upset stomach, depression, and sleep disturbance; lamotrigine with nervousness/agitation, upset stomach, and difficulty concentrating; and valproic acid with upset stomach and shaky hands." | 1.43 | Specific adverse effects of antiepileptic drugs--A true-to-life monotherapy study. ( Fidzinski, P; Gaus, V; Holtkamp, M; Kowski, AB; Losch, F; Weissinger, F, 2016) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 1 (12.50) | 18.2507 |
2000's | 1 (12.50) | 29.6817 |
2010's | 3 (37.50) | 24.3611 |
2020's | 3 (37.50) | 2.80 |
Authors | Studies |
---|---|
Panebianco, M | 2 |
Bresnahan, R | 2 |
Ramaratnam, S | 1 |
Marson, AG | 2 |
Stunnenberg, BC | 1 |
LoRusso, S | 1 |
Arnold, WD | 1 |
Barohn, RJ | 1 |
Cannon, SC | 1 |
Fontaine, B | 1 |
Griggs, RC | 1 |
Hanna, MG | 1 |
Matthews, E | 1 |
Meola, G | 1 |
Sansone, VA | 1 |
Trivedi, JR | 1 |
van Engelen, BGM | 1 |
Vicart, S | 1 |
Statland, JM | 1 |
Tentolouris-Piperas, V | 1 |
Lee, G | 1 |
Reading, J | 1 |
O'Keeffe, AG | 1 |
Zakrzewska, JM | 1 |
Cregg, R | 1 |
Benbadis, S | 1 |
Klein, P | 1 |
Schiemann, J | 1 |
Diaz, A | 1 |
Elmoufti, S | 1 |
Whitesides, J | 1 |
Kowski, AB | 1 |
Weissinger, F | 1 |
Gaus, V | 1 |
Fidzinski, P | 1 |
Losch, F | 1 |
Holtkamp, M | 1 |
Shechter, T | 1 |
Shorer, Z | 1 |
Kramer, U | 1 |
Lerman-Sagie, T | 1 |
Ronen, E | 1 |
Rotem, R | 1 |
Gorodischer, R | 1 |
Gillham, R | 1 |
Baker, G | 1 |
Thompson, P | 1 |
Birbeck, K | 1 |
McGuire, A | 1 |
Tomlinson, L | 1 |
Eckersley, L | 1 |
Silveira, C | 1 |
Brown, S | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures[NCT00464269] | Phase 3 | 400 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures[NCT01261325] | Phase 3 | 768 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.[NCT00490035] | Phase 3 | 399 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures.~All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | seizures per week (Median) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 2.15 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 1.80 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 1.96 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 1.77 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 2.79 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 4.26 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 6.36 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 3.37 |
"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 1.97 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 7.03 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 7.73 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 2.06 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 2.14 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 1.69 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 2.07 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 1.97 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 6.41 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 2.24 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 3.94 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 0.45 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 8.1 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 6.9 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 7.3 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 5.5 |
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 7.44 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 7.32 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 6.55 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 7.99 |
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 5.36 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 4.97 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 4.82 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 5.81 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 1.02 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | -2.61 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 0.73 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 6.07 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 5.49 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 3.39 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 3.66 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 2.33 |
"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 9.36 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 3.34 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 3.69 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 5.97 |
"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 3.88 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 4.07 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 5.19 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 2.88 |
"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | seizures per week (Median) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 2.15 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 1.80 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 1.96 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 1.70 |
"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | Percent change in POS frequency (Median) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 17.75 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 19.95 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 22.52 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 30.47 |
The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | percentage of participants (Number) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 56.3 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 50.0 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 77.8 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 63.6 |
The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | days (Median) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 15 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 14 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 17 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 19 |
The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | days (Median) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 3 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 4 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 5 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 4 |
The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | days (Median) |
---|---|
Modified Intention-to-Treat (Placebo Treated Subjects) | 28 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 30 |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 34 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 37 |
"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
<-25 % | -25 % to < 25 % | 25 % to < 50 % | 50 % to < 75 % | 75 % to < 100 % | 100 % | |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 14.1 | 38.4 | 24.2 | 15.2 | 6.1 | 2.0 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 21.9 | 31.3 | 25.0 | 12.5 | 8.3 | 1.0 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 9.9 | 31.7 | 25.7 | 19.8 | 8.9 | 4.0 |
Modified Intention-to-Treat (Placebo Treated Subjects) | 14.6 | 44.8 | 24.0 | 12.5 | 4.2 | 0 |
The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.' (NCT00464269)
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Intervention | percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Marked improvement | Moderate improvement | Slight improvement | No change | Slight worsening | Moderate worsening | Marked worsening | |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 17.2 | 18.2 | 31.3 | 32.3 | 1.0 | 0 | 0 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 12.2 | 18.9 | 24.4 | 34.4 | 2.2 | 7.8 | 0 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 16.3 | 27.6 | 24.5 | 25.5 | 2.0 | 3.1 | 1.0 |
Modified Intention-to-Treat (Placebo Treated Subjects) | 12.6 | 20.0 | 21.1 | 41.1 | 3.2 | 1.1 | 1.1 |
Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?' (NCT00464269)
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Intervention | percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Marked improvement | Moderate improvement | Slight improvement | No change | Slight worsening | Moderate worsening | Marked worsening | |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 18.8 | 26.3 | 21.3 | 27.5 | 1.3 | 3.8 | 1.3 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 19.8 | 24.7 | 18.5 | 23.5 | 6.2 | 7.4 | 0 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 26.7 | 19.8 | 22.1 | 23.3 | 4.7 | 1.2 | 2.3 |
Modified Intention-to-Treat (Placebo Treated Subjects) | 15.5 | 25.0 | 23.8 | 28.6 | 4.8 | 1.2 | 1.2 |
The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | participants (Number) | |
---|---|---|
Responders | Non-responders | |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 23 | 76 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 21 | 75 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 33 | 68 |
Modified Intention-to-Treat (Placebo Treated Subjects) | 16 | 80 |
"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Seizure-free | No seizures but non-completer | Not seizure-free | |
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | 1.0 | 1.0 | 98.0 |
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | 1.0 | 0 | 99.0 |
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | 4.0 | 0 | 96.0 |
Modified Intention-to-Treat (Placebo Treated Subjects) | 0 | 0 | 100.0 |
(NCT01261325)
Timeframe: 12 week Treatment Period
Intervention | number of seizures/ 28-day (Median) |
---|---|
Placebo | 8.7 |
Brivaracetam 100 mg/Day | 6.3 |
Brivaracetam 200 mg/Day | 5.8 |
(NCT01261325)
Timeframe: Baseline to 12 week Treatment Period
Intervention | percentage of change (Median) |
---|---|
Placebo | 17.6 |
Brivaracetam 100 mg/Day | 37.2 |
Brivaracetam 200 mg/Day | 35.6 |
Primary endpoint: United States of America (FDA) (NCT01261325)
Timeframe: 12 week Treatment Period
Intervention | Percentage of reduction (Number) |
---|---|
Brivaracetam 100 mg/Day | 22.8 |
Brivaracetam 200 mg/Day | 23.2 |
Placebo | 0 |
(NCT01261325)
Timeframe: 12 week Treatment Period
Intervention | days (Median) |
---|---|
Placebo | 16 |
Brivaracetam 100 mg/Day | 21 |
Brivaracetam 200 mg/Day | 23 |
(NCT01261325)
Timeframe: 12 week Treatment Period
Intervention | days (Median) |
---|---|
Placebo | 3 |
Brivaracetam 100 mg/Day | 5 |
Brivaracetam 200 mg/Day | 6 |
(NCT01261325)
Timeframe: 12 week Treatment Period
Intervention | days (Median) |
---|---|
Placebo | 32 |
Brivaracetam 100 mg/Day | 37 |
Brivaracetam 200 mg/Day | 43 |
Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration. (NCT01261325)
Timeframe: Baseline to 12 week Treatment Period
Intervention | Percentage of subjects (Number) | |
---|---|---|
Responders | Non-Responders | |
Brivaracetam 100 mg/Day | 38.9 | 61.1 |
Brivaracetam 200 mg/Day | 37.8 | 62.2 |
Placebo | 21.6 | 78.4 |
(NCT01261325)
Timeframe: Baseline to 12 week Treatment Period
Intervention | percentage of subjects (Number) | |||||
---|---|---|---|---|---|---|
<-25 % | -25 % to <25 % | 25 % to <50 % | 50 % to <75 % | 75 % to <100 % | 100 % | |
Brivaracetam 100 mg/Day | 14.3 | 28.6 | 18.3 | 19.0 | 13.9 | 6.0 |
Brivaracetam 200 mg/Day | 10.8 | 29.3 | 22.1 | 18.1 | 13.7 | 6.0 |
Placebo | 16.6 | 40.5 | 21.2 | 13.9 | 6.9 | 0.8 |
(NCT01261325)
Timeframe: 12 week Treatment Period
Intervention | percentage of subjects (Number) | ||
---|---|---|---|
Seizure free | No seizures but discontinued | Not seizure free | |
Brivaracetam 100 mg/Day | 5.2 | 1.2 | 93.7 |
Brivaracetam 200 mg/Day | 4.0 | 1.2 | 94.8 |
Placebo | 0.8 | 0.4 | 98.8 |
There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III). (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Times per week (Median) |
---|---|
Placebo | 1.75 |
Brivaracetam 20 mg/Day | 1.34 |
Brivaracetam 50 mg/Day | 1.49 |
Brivaracetam 100 mg/Day | 1.26 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 1.80 |
Brivaracetam 20 mg/Day | 5.36 |
Brivaracetam 50 mg/Day | 1.02 |
Brivaracetam 100 mg/Day | 0.69 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | -2.09 |
Brivaracetam 20 mg/Day | 3.35 |
Brivaracetam 50 mg/Day | 3.09 |
Brivaracetam 100 mg/Day | 3.50 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 3.80 |
Brivaracetam 20 mg/Day | 3.75 |
Brivaracetam 50 mg/Day | 3.13 |
Brivaracetam 100 mg/Day | -2.45 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 3.49 |
Brivaracetam 20 mg/Day | 3.53 |
Brivaracetam 50 mg/Day | 1.95 |
Brivaracetam 100 mg/Day | 1.99 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 6.6 |
Brivaracetam 20 mg/Day | 6.9 |
Brivaracetam 50 mg/Day | 9.7 |
Brivaracetam 100 mg/Day | 4.9 |
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | -1.54 |
Brivaracetam 20 mg/Day | -0.59 |
Brivaracetam 50 mg/Day | -0.41 |
Brivaracetam 100 mg/Day | 0.08 |
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | -0.65 |
Brivaracetam 20 mg/Day | -0.10 |
Brivaracetam 50 mg/Day | 0.26 |
Brivaracetam 100 mg/Day | -0.24 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 0.92 |
Brivaracetam 20 mg/Day | 3.64 |
Brivaracetam 50 mg/Day | -0.85 |
Brivaracetam 100 mg/Day | 3.00 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 5.11 |
Brivaracetam 20 mg/Day | 4.52 |
Brivaracetam 50 mg/Day | 4.55 |
Brivaracetam 100 mg/Day | 2.24 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 8.25 |
Brivaracetam 20 mg/Day | 6.23 |
Brivaracetam 50 mg/Day | 5.34 |
Brivaracetam 100 mg/Day | 8.04 |
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 2.29 |
Brivaracetam 20 mg/Day | 4.50 |
Brivaracetam 50 mg/Day | 3.09 |
Brivaracetam 100 mg/Day | 1.78 |
"The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: Assess the Overall change in the severity of patient's illness, compared to start of study medication." (NCT00490035)
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 4.78 |
Brivaracetam 20 mg/Day | 4.99 |
Brivaracetam 50 mg/Day | 4.99 |
Brivaracetam 100 mg/Day | 5.34 |
Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Seizure Frequency per Week (Median) |
---|---|
Placebo | 1.75 |
Brivaracetam 20 mg/Day | 1.34 |
Brivaracetam 50 mg/Day | 1.49 |
Brivaracetam 100 mg/Day | 1.26 |
"The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: Overall, has there been a change in your seizures since the start of the study medication?" (NCT00490035)
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Intervention | units on a scale (Mean) |
---|---|
Placebo | 4.93 |
Brivaracetam 20 mg/Day | 5.17 |
Brivaracetam 50 mg/Day | 5.04 |
Brivaracetam 100 mg/Day | 5.47 |
The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Percent change in seizures per week (Median) |
---|---|
Placebo | -17.03 |
Brivaracetam 20 mg/Day | -30.03 |
Brivaracetam 50 mg/Day | -26.83 |
Brivaracetam 100 mg/Day | -32.45 |
The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | percentage of participants (Number) |
---|---|
Placebo | 45.9 |
Brivaracetam 20 mg/Day | 47.2 |
Brivaracetam 50 mg/Day | 62.5 |
Brivaracetam 100 mg/Day | 41.0 |
The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Days (Median) |
---|---|
Placebo | 19 |
Brivaracetam 20 mg/Day | 25 |
Brivaracetam 50 mg/Day | 24 |
Brivaracetam 100 mg/Day | 24 |
The time to first Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Days (Median) |
---|---|
Placebo | 4 |
Brivaracetam 20 mg/Day | 6 |
Brivaracetam 50 mg/Day | 6 |
Brivaracetam 100 mg/Day | 4 |
The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Days (Median) |
---|---|
Placebo | 39 |
Brivaracetam 20 mg/Day | 49 |
Brivaracetam 50 mg/Day | 40 |
Brivaracetam 100 mg/Day | 46 |
"The categories are:~<= 25 %~- 25 % to < 25 %~25 % to < 50 %~50 % to < 75 %~75 % to < 100 %~100 %" (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Percentage of Participants (Number) | |||||
---|---|---|---|---|---|---|
<= 25 % | - 25 % to < 25 % | 25 % to < 50 % | 50 % to < 75 % | 75 % to < 100 % | 100 % | |
Brivaracetam 100 mg/Day | 10.0 | 33.0 | 21.0 | 14.0 | 18.0 | 4.0 |
Brivaracetam 20 mg/Day | 10.1 | 35.4 | 27.3 | 18.2 | 7.1 | 2.0 |
Brivaracetam 50 mg/Day | 15.2 | 33.3 | 24.2 | 17.2 | 9.1 | 1.0 |
Placebo | 19.0 | 41.0 | 20.0 | 12.0 | 8.0 | 0 |
"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.~The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline." (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Percentage of Participants (Number) | |
---|---|---|
Non-responders | Responders | |
Brivaracetam 100 mg/Day | 64.0 | 36.0 |
Brivaracetam 20 mg/Day | 72.7 | 27.3 |
Brivaracetam 50 mg/Day | 72.7 | 27.3 |
Placebo | 80.0 | 20.0 |
Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period
Intervention | Percentage of Participants (Number) | ||
---|---|---|---|
Seizure free | No Seizures but non-completer | Not Seizure-free | |
Brivaracetam 100 mg/Day | 4.0 | 0 | 96.0 |
Brivaracetam 20 mg/Day | 2.0 | 0 | 98.0 |
Brivaracetam 50 mg/Day | 0 | 1.0 | 99.0 |
Placebo | 0 | 0 | 100.0 |
3 reviews available for lamotrigine and Fatigue
Article | Year |
---|---|
Lamotrigine add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Ataxia; Child; Cognition; Cross-Over Studies; Diplopia; Dizziness; Drug Resi | 2020 |
Guidelines on clinical presentation and management of nondystrophic myotonias.
Topics: Acetazolamide; Age of Onset; Carbonic Anhydrase Inhibitors; Chloride Channels; Electrodiagnosis; Ele | 2020 |
Lamotrigine add-on therapy for drug-resistant generalised tonic-clonic seizures.
Topics: Anticonvulsants; Chemotherapy, Adjuvant; Dizziness; Drug Eruptions; Drug Resistant Epilepsy; Epileps | 2020 |
2 trials available for lamotrigine and Fatigue
3 other studies available for lamotrigine and Fatigue
Article | Year |
---|---|
Adverse effects of anti-epileptics in trigeminal neuralgiform pain.
Topics: Adult; Aged; Anticonvulsants; Carbamazepine; Cross-Sectional Studies; Fatigue; Female; Humans; Lamot | 2018 |
Specific adverse effects of antiepileptic drugs--A true-to-life monotherapy study.
Topics: Adult; Aged; Anticonvulsants; Anxiety; Carbamazepine; Depression; Drug-Related Side Effects and Adve | 2016 |
Adverse reactions of Topiramate and Lamotrigine in children.
Topics: Adolescent; Adverse Drug Reaction Reporting Systems; Anticonvulsants; Child; Child, Preschool; Cross | 2005 |