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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN: 94839639 | |||
| EudraCT Number:2005-003324-19 |
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| Name | Class |
|---|---|
| UCB Pharma GmbH | INDUSTRY |
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In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.
Indication: Focal Epilepsy Objectives: To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamotrigine (LTG) or carbamazepine slow release (CBZ).
Primary Outcome: The primary outcome will be the 58-week retention rate measured by the number of drop outs due to adverse events or seizures from day 1 of treatment.
Secondary Outcome: Proportion of patients remaining seizure-free at week 30 (Visit 4); proportion of patients remaining seizure free at week 58 (Visit 6); the time (in days) to first break-through seizure (from day 1 of treatment); the absolute seizure frequency during the maintenance (over 52 weeks) phase; proportion of seizure-free days during the maintenance phase for subjects who enter the maintenance phase; the frequency of adverse events (from day 1 of treatment); QOLIE-31 results at V6; Portland Neurotoxicity scale at V6; results of cognitive testing (EpiTrack© by UCB).
Trial Design: This is a randomized, double-blind, multicenter Phase IV study using a parallel group design with three treatment groups. The study will consist of a 6-week titration-phase and a 52-week maintenance phase. Patients who successfully complete the trial (final visit, V6) will be unblinded and offered either to continue on their current drug or be changed to an alternative antiepileptic drug (AED) treatment of choice.
Population: Patients aged 60 years or above with new onset focal epilepsy i.e. either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CT/MRI or a total of 2 epileptic seizures, one of which occurring in the last 6 months prior inclusion. Patients with acute (< 2 weeks) symptomatic epileptic seizures due to acute brain abnormalities (i.e. haemorrhage or cerebral infarct), or contraindications against any of the drugs in trial will be excluded.
Sample Size: 360 patients to be included, 120 patients per treatment arm. Investigational Medicinal Product(s): Levetiracetam, lamotrigine, carbamazepine-slow release Trial Duration and Dates: Duration of treatment: 6 weeks titration phase, 52 weeks maintenance phase.
Follow up: At the end of trial subjects will be unblinded and may choose to continue on the medication or taper the trial medication and be treated with an alternative drug at the investigators discretion. The patient will receive a dosing schedule and a referral letter for his/her physician.
Duration of trial: approximately 2 years. Start of recruitment: January 2007 Projected number of centres: 75 Number of countries: 3 (Germany, Switzerland, Austria).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator | Levetiracetam |
|
| Carbamazepine | Active Comparator | Carbamazepine |
|
| Lamotrigine | Active Comparator | Lamotrigine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | 58 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Drop Out | number of days between randomization and premature discontinuation of the study | 58 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad J Werhahn, MD | Johannes Gutenberg University, Department od Neurology | Study Chair |
| Günter Kraemer, MD | Swiss Epilepy Centre | Study Director |
| Eugen Trinka, MD | Medical University of Salzburg, Department of Neurology, Austria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University of Mainz Medical Centre | Mainz | 55101 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15955935 | Background | Rowan AJ, Ramsay RE, Collins JF, Pryor F, Boardman KD, Uthman BM, Spitz M, Frederick T, Towne A, Carter GS, Marks W, Felicetta J, Tomyanovich ML; VA Cooperative Study 428 Group. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology. 2005 Jun 14;64(11):1868-73. doi: 10.1212/01.WNL.0000167384.68207.3E. | |
| 12199724 |
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In total, 361 patients were randomized. 359 patients were analysed ITT (patient 0213 did not suffer from epilepsy, patient 3604 should not have been asked for informed consent, because of his legal guardianship).
43 study centres in three countries participated in this study (31 in Germany, 5 in Austria, 7 in Switzerland). The number of patients recruited in each country (242 Germany, 55 Austria, 29 Switzerland) and per centre (range from 1 to 53) was heterogeneous.
Therefore, centre effects were explored by pooling the centres with less than 20 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed. |
| FG001 | Carbamazepine | Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed. |
| FG002 | Lamotrigine | Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Levetiracetam 250mg |
| BG001 | Carbamazepine | Carbamazepine 100mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age is shown for ITT population |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | Posted | Mean | 95% Confidence Interval | proportion of participants | 58 weeks |
|
Adverse events were recorded from day 1 of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | Levetiracetam 250mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C. Ruckes | Interdisciplinary Center for Clinical Trials (IZKS Mainz) | +49 (0) 6131 17 | 9919 | ruckes@izks-mainz.de |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D002220 | Carbamazepine |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Carbamazepine | Drug | CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy. |
|
| Lamotrigine | Drug | LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy. |
|
| Week 30 |
| 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. | week 58 |
| The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment) | over the whole duration of 58 weeks |
| 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. | over 52 weeks |
| Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase | 52 weeks |
| 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. | 58 weeks, final visit |
| 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. | at week 58 |
| 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. | week 58 |
| 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 | 58 weeks |
| 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 | week 58 |
| Brodie MJ, Chadwick DW, Anhut H, Otte A, Messmer SL, Maton S, Sauermann W, Murray G, Garofalo EA; Gabapentin Study Group 945-212. Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Epilepsia. 2002 Sep;43(9):993-1000. doi: 10.1046/j.1528-1157.2002.45401.x. |
| 25684224 | Derived | Werhahn KJ, Trinka E, Dobesberger J, Unterberger I, Baum P, Deckert-Schmitz M, Kniess T, Schmitz B, Bernedo V, Ruckes C, Ehrlich A, Kramer G. A randomized, double-blind comparison of antiepileptic drug treatment in the elderly with new-onset focal epilepsy. Epilepsia. 2015 Mar;56(3):450-9. doi: 10.1111/epi.12926. Epub 2015 Feb 12. |
| BG002 |
| Lamotrigine |
Lamotrigine 25mg |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Gender is shown for ITT population | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race is shown for ITT population | Count of Participants | Participants |
|
| Region of Enrollment | Region of enrollment is shown for ITT population | Number | participants |
|
| Epilepsy history - number of seizures | is shown for ITT population | Mean | Standard Deviation | number of seizures |
|
| Epilepsy history - Aura | is shown for ITT population "NA" refer to the fact that the epilepsy history - Aura is unknown | Number | participants |
|
| Epilepsy history - Autonomic seizure | is shown for ITT population | Number | participants |
|
| Epilepsy history - Dialeptic seizure | is shown for ITT population | Number | participants |
|
| Epilepsy history - Motor seizure | is shown for ITT population | Number | participants |
|
| Epileptic history - Special seizure | is shown for ITT population | Number | participants |
|
| EEG (electroencephalogram) pathological | is shown for ITT population | Number | participants |
|
| MRT (Magnetic Resonance Tomograhy) pathological | is shown for ITT population | Number | participants |
|
| CCT (Cranial Computed Tomography) pathological | is shown for ITT population | Number | participants |
|
Lamotrigine 25mg |
|
|
|
| Secondary | Time to Drop Out | number of days between randomization and premature discontinuation of the study | ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | Posted | Median | 95% Confidence Interval | days | 58 weeks |
|
|
|
|
| Secondary | 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. | ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | Posted | Number | percentage of participants | Week 30 |
|
|
|
|
| Secondary | 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. | ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | Posted | Number | percentage of participants | week 58 |
|
|
|
|
| Secondary | The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment) | ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | Posted | Median | 95% Confidence Interval | days | over the whole duration of 58 weeks |
|
|
|
|
| Secondary | 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. | Completer population: The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment). | Posted | Number | number of seizures | over 52 weeks |
|
|
|
| Secondary | Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase | Patients of ITT population who reached the maintenance phase | Posted | Number | proportion of seizure-free days | 52 weeks |
|
|
|
| Secondary | 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. | Patients of ITT population who filled out QOLIE-31 at V6 | Posted | Mean | Standard Deviation | units on a scale | 58 weeks, final visit |
|
|
|
| Secondary | 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. | Patients of ITT population who filled out PNS at V6 | Posted | Mean | Standard Deviation | units on a scale | at week 58 |
|
|
|
| Secondary | 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. | Patients of ITT population who had data at V6 | Posted | Mean | Standard Deviation | units on a scale | week 58 |
|
|
|
| Secondary | 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 | Patients of ITT population with data at V6 | Posted | Number | participants | 58 weeks |
|
|
|
| Secondary | 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 | Patients of ITT population with data at V6 and V0 | Posted | Number | participants | week 58 |
|
|
|
| 33 |
| 122 |
| 108 |
| 122 |
| EG001 | Carbamazepine | Carbamazepine 100mg | 36 | 121 | 108 | 121 |
| EG002 | Lamotrigine | Lamotrigine 25mg | 32 | 117 | 110 | 117 |
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Acute mycardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hernia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Infectious peritonitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Helicobacter test positive | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Anaplastic astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Amnestic disorder | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Complex partial seizures | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Stupor | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Suicidal behavior | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Bursa removal | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Meningioma surgery | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sleep disorder | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
This study was supported (as investigator-initated trial) by an educational grant from UCB GmbH, Germany. A disclosure restriction applies on the PI in that UCB can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted. As of Jan-01-2012 the study chair is an employee to UCB Biosciences GmbH working as Medical Director in the Therapeutic Area CNS within Global Projects and Development.
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014227 | Triazines |
| Overall quality of life |
|
| Emotional well-being |
|
| Energy/fatigue |
|
| Cognitive functioning |
|
| Medication effects |
|
| Social functioning |
|
| Total Score |
|
| Health Scale |
|
| Somatomotor subscore |
|
| Total Score |
|
|
| Impaired |
|
| Title | Measurements |
|---|---|
|
| Worsened |
|