PASS: Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
Sponsor
UCB Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00771927
Collaborator
(none)
1,005
62
41
16.2
0.4
Study Details
Study Description
Brief Summary
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
1005 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Mar 1, 2012
Actual Study Completion Date
:
Mar 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Lacosamide Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat |
Drug: Lacosamide
Vimpat was used as per site routine practices, and in-line with the marketing authorization.
Other Names:
|
| Other AED Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy |
Outcome Measures
Primary Outcome Measures
- The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study [From Baseline up to 12 months]
Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
Secondary Outcome Measures
- The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study [From Baseline up to 12 months]
Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy
-
Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study
-
The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bron | France | |||
| 2 | Dijon | France | |||
| 3 | La Tronche | France | |||
| 4 | Montpellier | France | |||
| 5 | Nantes | France | |||
| 6 | Paris | France | |||
| 7 | Saint Brieuc | France | |||
| 8 | Tain L'Hermitage | France | |||
| 9 | Aschaffenburg | Germany | |||
| 10 | Bad Berka | Germany | |||
| 11 | Berlin | Germany | |||
| 12 | Bernau | Germany | |||
| 13 | Bielefeld | Germany | |||
| 14 | Bonn | Germany | |||
| 15 | Dresden | Germany | |||
| 16 | Dusseldorf | Germany | |||
| 17 | Erlangen | Germany | |||
| 18 | Essen | Germany | |||
| 19 | Freiburg | Germany | |||
| 20 | Gottingen | Germany | |||
| 21 | Halle | Germany | |||
| 22 | Hamburg | Germany | |||
| 23 | Jena | Germany | |||
| 24 | Kehl-Kork | Germany | |||
| 25 | Kiel | Germany | |||
| 26 | Koningstein-Falkenstein | Germany | |||
| 27 | Krefeld | Germany | |||
| 28 | Mainz | Germany | |||
| 29 | Marburg | Germany | |||
| 30 | Munster | Germany | |||
| 31 | München | Germany | |||
| 32 | Neuburg | Germany | |||
| 33 | Neukirchen-Vluyn | Germany | |||
| 34 | Oldenburg | Germany | |||
| 35 | Osnabruck | Germany | |||
| 36 | Potsdam | Germany | |||
| 37 | Radeberg, Sachsen | Germany | |||
| 38 | Ravensburg | Germany | |||
| 39 | Rotenburg/Wümme | Germany | |||
| 40 | Stuttgart | Germany | |||
| 41 | Ulm | Germany | |||
| 42 | Vogtareuth | Germany | |||
| 43 | Westerstede | Germany | |||
| 44 | Blaricum | Netherlands | |||
| 45 | Heeze | Netherlands | |||
| 46 | Nijmegen | Netherlands | |||
| 47 | Barcelona | Spain | |||
| 48 | El Vendrell | Spain | |||
| 49 | Plymouth | Devon | United Kingdom | ||
| 50 | Fulwood, Preston | Lancashire | United Kingdom | ||
| 51 | Bangor | United Kingdom | |||
| 52 | Birmingham | United Kingdom | |||
| 53 | Cardiff | United Kingdom | |||
| 54 | Dundee | United Kingdom | |||
| 55 | Edinburgh | United Kingdom | |||
| 56 | Leeds | United Kingdom | |||
| 57 | Leicester | United Kingdom | |||
| 58 | London | United Kingdom | |||
| 59 | Middlesborough | United Kingdom | |||
| 60 | Salford | United Kingdom | |||
| 61 | Sheffield | United Kingdom | |||
| 62 | Stoke on Trent | United Kingdom |
Sponsors and Collaborators
- UCB Pharma
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00771927
Other Study ID Numbers:
- SP0942
First Posted:
Oct 15, 2008
Last Update Posted:
Oct 27, 2014
Last Verified:
May 1, 2013
Keywords provided by UCB Pharma
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were enrolled into 1 of 2 groups in this study (500 unique patients per group) at the discretion of the treating physician: patients treated with Vimpat as add-on to their current Anti-Epileptic Drug (AED) therapy (group 1) and patients treated with other approved AEDs as add-on (group 2). |
|---|---|
| Pre-assignment Detail | Patient procedures and assessments were performed in the frame of the current standard practice at the discretion of the treating physician. Each patient was followed for the initial 12 months of add-on AED treatment. A Safety Follow-Up Visit is recommended for any patient who terminates add-on AED treatment before the end of the study period. |
| Arm/Group Title | Lacosamide | Other AED |
|---|---|---|
| Arm/Group Description | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy |
| Period Title: Overall Study | ||
| STARTED | 511 | 493 |
| COMPLETED | 256 | 256 |
| NOT COMPLETED | 255 | 237 |
Baseline Characteristics
| Arm/Group Title | Lacosamide | Other AED | Total |
|---|---|---|---|
| Arm/Group Description | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy | Total of all reporting groups |
| Overall Participants | 511 | 493 | 1004 |
| Age (Count of Participants) | |||
| <=18 years |
20
3.9%
|
14
2.8%
|
34
3.4%
|
| Between 18 and 65 years |
467
91.4%
|
434
88%
|
901
89.7%
|
| >=65 years |
24
4.7%
|
45
9.1%
|
69
6.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
39.8
(13.58)
|
42.3
(15.38)
|
41.0
(14.54)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
266
52.1%
|
282
57.2%
|
548
54.6%
|
| Male |
245
47.9%
|
211
42.8%
|
456
45.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
0.2%
|
1
0.1%
|
| Asian |
5
1%
|
4
0.8%
|
9
0.9%
|
| Native Hawaiian or Other Pacific Islander |
1
0.2%
|
0
0%
|
1
0.1%
|
| Black or African American |
0
0%
|
1
0.2%
|
1
0.1%
|
| White |
481
94.1%
|
464
94.1%
|
945
94.1%
|
| More than one race |
0
0%
|
1
0.2%
|
1
0.1%
|
| Unknown or Not Reported |
24
4.7%
|
22
4.5%
|
46
4.6%
|
| Weight (kilogram) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilogram] |
75.5
(18.10)
|
75.7
(17.68)
|
75.6
(17.89)
|
| Height (centimeter) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [centimeter] |
170.4
(10.97)
|
169.5
(9.24)
|
170.0
(10.18)
|
| Body Mass Index (BMI) (kilogram per square meter) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilogram per square meter] |
26.0
(5.89)
|
26.2
(5.25)
|
26.1
(5.59)
|
Outcome Measures
| Title | The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study |
|---|---|
| Description | Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake. |
| Time Frame | From Baseline up to 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (SS) population |
| Arm/Group Title | Lacosamide | Other AED |
|---|---|---|
| Arm/Group Description | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy |
| Measure Participants | 511 | 493 |
| Number [Treatment-Emergent Adverse Events] |
4
|
3
|
| Title | The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study |
|---|---|
| Description | Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake. |
| Time Frame | From Baseline up to 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (SS) population |
| Arm/Group Title | Lacosamide | Other AED |
|---|---|---|
| Arm/Group Description | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy |
| Measure Participants | 511 | 493 |
| Number [Treatment-Emergent Adverse Events] |
22
|
31
|
Adverse Events
| Time Frame | Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once. | |||
| Arm/Group Title | Lacosamide | Other AED | ||
| Arm/Group Description | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy | ||
All Cause Mortality |
||||
| Lacosamide | Other AED | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lacosamide | Other AED | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 78/511 (15.3%) | 64/493 (13%) | ||
| Blood and lymphatic system disorders | ||||
| Leukopenia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Lymphadenopathy | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Cardiac disorders | ||||
| Atrial Flutter | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Atrial Fibrillation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Palpitations | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Tachycardia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Acute Coronary Syndrome | 0/511 (0%) | 0 | 1/493 (0.2%) | 2 |
| Left Ventricular Failure | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Congenital, familial and genetic disorders | ||||
| Foetal Malformation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Sudden Hearing Loss | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Eye disorders | ||||
| Diplopia | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Nausea | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Abdominal Pain Upper | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Umbilical Hernia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Vomiting | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Anorectal Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| General disorders | ||||
| Cyst Rupture | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Drug Ineffective | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Gait Disturbance | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Idiosyncratic Drug Reaction | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Pyrexia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Sudden Unexplained Death in Epilepsy | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Death | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Fatigue | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Infections and infestations | ||||
| Furuncle | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Infection | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Bronchopneumonia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Gastroenteritis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Gastrointestinal Infection | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Respiratory Tract Infection | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fall | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Brain Contusion | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Contusion | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Facial Bones Fracture | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Femur Fracture | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Foot Fracture | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Jaw Fracture | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Rib Fracture | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Thermal Burn | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Upper Limb Fracture | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Vascular Graft Complication | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Concussion | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Ligament Rupture | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Meniscus Lesion | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Post-Traumatic Neck Syndrome | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Road Traffic Accident | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Spinal Fracture | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Subdural Haematoma | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Investigations | ||||
| Electroencephalogram | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Weight Increased | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Investigation | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||||
| Hyponatraemia | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Spinal Osteoarthritis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignant Glioma | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Neoplasm Progression | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Anal Cancer | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Nervous system disorders | ||||
| Convulsion | 16/511 (3.1%) | 18 | 17/493 (3.4%) | 21 |
| Epilepsy | 7/511 (1.4%) | 7 | 3/493 (0.6%) | 3 |
| Dizziness | 4/511 (0.8%) | 4 | 1/493 (0.2%) | 1 |
| Grand Mal Convulsion | 3/511 (0.6%) | 3 | 11/493 (2.2%) | 12 |
| Headache | 3/511 (0.6%) | 3 | 4/493 (0.8%) | 4 |
| Status Epilepticus | 3/511 (0.6%) | 3 | 1/493 (0.2%) | 1 |
| Seizure Cluster | 2/511 (0.4%) | 4 | 1/493 (0.2%) | 1 |
| Ataxia | 1/511 (0.2%) | 2 | 0/493 (0%) | 0 |
| Balance Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Complex Partial Seizures | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Hemiparesis | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Neuralgia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Partial Seizures | 1/511 (0.2%) | 1 | 5/493 (1%) | 8 |
| Sciatica | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Somnolence | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Temporal Lobe Epilepsy | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Toxic Encephalopathy | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Cognitive Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Paraparesis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Postictal Paralysis | 0/511 (0%) | 0 | 1/493 (0.2%) | 2 |
| Psychomotor Seizures | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Psychiatric disorders | ||||
| Depression | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Emotional Disorder | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Suicide Attempt | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Anxiety Disorder | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Conversion Disorder | 1/511 (0.2%) | 2 | 0/493 (0%) | 0 |
| Delirium | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Disturbance in Social Behaviour | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Generalised Anxiety Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Mental Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Somatoform Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Aggression | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Expressive Language Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Panic Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Personality Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Psychotic Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Renal and urinary disorders | ||||
| Pollakiuria | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Rash Generalised | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Surgical and medical procedures | ||||
| Abortion Induced | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Brain Operation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Abscess Drainage | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Vascular disorders | ||||
| Hypertensive Crisis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Lacosamide | Other AED | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 359/511 (70.3%) | 299/493 (60.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/511 (0.2%) | 1 | 3/493 (0.6%) | 3 |
| Leukocytosis | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Thrombocytopenia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Leukopenia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Neutropenia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Cardiac disorders | ||||
| Angina Pectoris | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Bundle Branch Block Right | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Sinus Bradycardia | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Ventricular Exrasystoles | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Atrioventricular Block First Degree | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Bradycardia | 1/511 (0.2%) | 1 | 3/493 (0.6%) | 3 |
| Conduction Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Palpitations | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Sinus Tachycardia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Supraventricular Extrasystoles | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Atrial Fibrillation | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Bundle Branch Block Left | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Tachycardia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Congenital, familial and genetic disorders | ||||
| Arteriovenous Malformation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo | 44/511 (8.6%) | 49 | 11/493 (2.2%) | 12 |
| Eustachian Tube Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Tinnitus | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Vestibular Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| External Ear Inflammation | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Hypoacusis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Endocrine disorders | ||||
| Hyperthyroidism | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Eye disorders | ||||
| Diplopia | 52/511 (10.2%) | 61 | 18/493 (3.7%) | 19 |
| Vision Blurred | 18/511 (3.5%) | 18 | 13/493 (2.6%) | 13 |
| Visual Impairment | 9/511 (1.8%) | 9 | 2/493 (0.4%) | 2 |
| Accomodation Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Blepharospasm | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Conjunctival Hyperaemia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Excessive Eye Blinking | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Eye Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Eye Haemorrhage | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Eye Pain | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Eye Swelling | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Ocular Discomfort | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Oscillopsia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Saccadic Eye Movement | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Abnormal Sensation in Eye | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Dry Eye | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Exophthalmos | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Photopsia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Retinal Infarction | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Visual Acuity Reduced | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Gastrointestinal disorders | ||||
| Nausea | 47/511 (9.2%) | 49 | 23/493 (4.7%) | 24 |
| Vomiting | 15/511 (2.9%) | 16 | 8/493 (1.6%) | 9 |
| Diarrhoea | 9/511 (1.8%) | 9 | 15/493 (3%) | 15 |
| Constipation | 6/511 (1.2%) | 6 | 8/493 (1.6%) | 8 |
| Abdominal Pain | 4/511 (0.8%) | 4 | 3/493 (0.6%) | 3 |
| Abdominal Pain Upper | 4/511 (0.8%) | 5 | 7/493 (1.4%) | 7 |
| Dyspepsia | 2/511 (0.4%) | 2 | 5/493 (1%) | 5 |
| Flatulence | 2/511 (0.4%) | 2 | 3/493 (0.6%) | 4 |
| Toothache | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Abdominal Distension | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Aphthous Stomatitis | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Gastric Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Gastrooesophageal Reflux Disease | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Glossodynia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Hypoaesthesia Oral | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Rectal Haemorrhage | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Salivary Hypersecretion | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Tongue Spasm | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Umbilical Hernia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Abdominal Discomfort | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Coeliac Disease | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Dry Mouth | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Dysphagia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Gastritis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Gingival Hyperplasia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Retching | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| General disorders | ||||
| Fatigue | 81/511 (15.9%) | 93 | 61/493 (12.4%) | 65 |
| Irritability | 11/511 (2.2%) | 12 | 13/493 (2.6%) | 14 |
| Gait Disturbance | 8/511 (1.6%) | 9 | 8/493 (1.6%) | 8 |
| Asthenia | 4/511 (0.8%) | 5 | 1/493 (0.2%) | 1 |
| Pyrexia | 4/511 (0.8%) | 4 | 1/493 (0.2%) | 1 |
| Non-Cardiac Chest Pain | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Oedema Peripheral | 2/511 (0.4%) | 2 | 4/493 (0.8%) | 4 |
| Adverse Drug Reaction | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Chills | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Implant Site Pain | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Oedema | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Pain | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Spinal Pain | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Chest Pain | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Drug Therapeutic Incompability | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Feeling Abnormal | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Feeling Cold | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Feeling Hot | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Malaise | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Temperature Intolerance | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Hepatobiliary disorders | ||||
| Hepatic Pain | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Immune system disorders | ||||
| Drug Hypersensitivity | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Hypersensitivity | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Infections and infestations | ||||
| Nasopharyngitis | 7/511 (1.4%) | 8 | 11/493 (2.2%) | 13 |
| Influenza | 3/511 (0.6%) | 3 | 0/493 (0%) | 0 |
| Sinusitis | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Abscess | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Cystitis | 1/511 (0.2%) | 4 | 0/493 (0%) | 0 |
| Device Related Infection | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dysentery | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Gastroenteritis | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| H1N1 Influenza | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Helicobacter Gastritis | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Infected Bites | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Intraspinal Abscess | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Lower Respiratory Tract Infection | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Vaginal Infection | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Viral Upper Respiratory Tract Infection | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Bronchitis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Rash Pustular | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Candidiasis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Pertussis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Pneumonia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Tooth Abscess | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Tooth Infection | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Urinary Tract Infection | 0/511 (0%) | 0 | 3/493 (0.6%) | 3 |
| Viral Infection | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Respiratory Tract Infection | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Contusion | 8/511 (1.6%) | 8 | 1/493 (0.2%) | 1 |
| Fall | 4/511 (0.8%) | 5 | 3/493 (0.6%) | 4 |
| Laceration | 4/511 (0.8%) | 5 | 2/493 (0.4%) | 2 |
| Ligament Sprain | 3/511 (0.6%) | 3 | 1/493 (0.2%) | 1 |
| Lumbar Vertebral Fracture | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Burns Third Degree | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Cervical Vertebral Fracture | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Face Injury | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Foot Fracture | 1/511 (0.2%) | 2 | 1/493 (0.2%) | 1 |
| Hand Fracture | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Joint Injury | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Limb Injury | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Muscle Strain | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Tooth Fracture | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Ankle Fracture | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Nail Injury | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Open Wound | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Rib Fracture | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Subdural Haematoma | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Investigations | ||||
| Weight Increased | 16/511 (3.1%) | 16 | 8/493 (1.6%) | 9 |
| Weight Decreased | 5/511 (1%) | 5 | 12/493 (2.4%) | 12 |
| Electrocardiogram QT Prolonged | 3/511 (0.6%) | 3 | 1/493 (0.2%) | 1 |
| Alanine Aminotransferase Increased | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Electroencephalogram | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Blood Cholesterol Increased | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Blood Glucose Abnormal | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Blood Pressure Decreased | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Electrocardiogram Q Wave Abnormal | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Electrocardiogram ST Segment Elevation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Electrocardiogram T Wave Inversion | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Gamma-Glutamyltransferase Increased | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Neurological Examination | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Neurological Examination Abnormal | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Activated Partial Thromboplastin Time Prolonged | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Blood Calcium Decreased | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Blood Creatine Phosphokinase Increased | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Blood Pressure Increased | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| C-Reactive Protein Increased | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Electrocardiogram Low Voltage | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Investigation | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased Appetite | 4/511 (0.8%) | 4 | 10/493 (2%) | 11 |
| Dehydration | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Lactose Intolerance | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Vitamin B12 Deficiency | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Vitamin D Deficiency | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Hypercholesterolaemia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Hyperhomocysteinaemia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Hypokalaemia | 0/511 (0%) | 0 | 1/493 (0.2%) | 2 |
| Hyponatraemia | 0/511 (0%) | 0 | 3/493 (0.6%) | 3 |
| Hypophagia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Increased Appetite | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Iron Deficiency | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Obesity | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Folate Deficiency | 0/511 (0%) | 0 | 3/493 (0.6%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 7/511 (1.4%) | 7 | 8/493 (1.6%) | 8 |
| Arthralgia | 5/511 (1%) | 5 | 1/493 (0.2%) | 1 |
| Muscle Spasms | 3/511 (0.6%) | 3 | 0/493 (0%) | 0 |
| Neck Pain | 3/511 (0.6%) | 3 | 1/493 (0.2%) | 1 |
| Muscular Weakness | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Musculoskeletal Pain | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Myalgia | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Pain in Extremity | 1/511 (0.2%) | 1 | 4/493 (0.8%) | 4 |
| Posture Abnormal | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Sensation of Heaviness | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Tenosynovitis Stenosans | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Arthritis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Bursitis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Muscle Tightness | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Oligodendroglioma | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Benign Anorectal Neoplasm | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 108/511 (21.1%) | 129 | 45/493 (9.1%) | 49 |
| Headache | 53/511 (10.4%) | 57 | 26/493 (5.3%) | 30 |
| Convulsion | 21/511 (4.1%) | 21 | 15/493 (3%) | 18 |
| Tremor | 20/511 (3.9%) | 24 | 12/493 (2.4%) | 15 |
| Ataxia | 16/511 (3.1%) | 17 | 8/493 (1.6%) | 8 |
| Memory Impairment | 16/511 (3.1%) | 16 | 14/493 (2.8%) | 14 |
| Somnolence | 14/511 (2.7%) | 16 | 7/493 (1.4%) | 7 |
| Aphasia | 11/511 (2.2%) | 11 | 12/493 (2.4%) | 12 |
| Balance Disorder | 10/511 (2%) | 11 | 4/493 (0.8%) | 4 |
| Disturbance in Attention | 8/511 (1.6%) | 8 | 8/493 (1.6%) | 8 |
| Nystagmus | 6/511 (1.2%) | 9 | 0/493 (0%) | 0 |
| Paraesthesia | 6/511 (1.2%) | 6 | 12/493 (2.4%) | 12 |
| Cognitive Disorder | 5/511 (1%) | 5 | 5/493 (1%) | 5 |
| Lethargy | 4/511 (0.8%) | 4 | 1/493 (0.2%) | 1 |
| Migraine | 4/511 (0.8%) | 4 | 2/493 (0.4%) | 2 |
| Speech Disorder | 4/511 (0.8%) | 4 | 4/493 (0.8%) | 4 |
| Amnesia | 3/511 (0.6%) | 3 | 1/493 (0.2%) | 1 |
| Epilepsy | 3/511 (0.6%) | 4 | 2/493 (0.4%) | 2 |
| Hypoaesthesia | 3/511 (0.6%) | 4 | 0/493 (0%) | 0 |
| Aura | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Coordination Abnormal | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Grand Mal Convulsion | 2/511 (0.4%) | 2 | 3/493 (0.6%) | 4 |
| Partial Seizures | 2/511 (0.4%) | 5 | 1/493 (0.2%) | 1 |
| Cerebellar Ataxia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Complex Partial Seizures | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 3 |
| Cubital Tunnel Syndrome | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dizziness Postural | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dysaesthesia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dysarthria | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Dysgeusia | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Dysgraphia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dyskinesia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Formication | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Hypertonia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Hypotonia | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Loss of Consciousness | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Myoclonus | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Poor Quality Sleep | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Psychomotor Hyperactivity | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Sciatica | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Sedation | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Simple Partial Seizures | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Transient Ischaemic Attack | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Altered State of Consciousness | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Cerebrovascular Accident | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Depressed Level of Consciousness | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Drug Withdrawal Convulsions | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Head Titubation | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Hypokinesia | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Intention Tremor | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Motor Dysfunction | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Myoclonic Epilepsy | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Nerve Compression | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Paralysis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Parosmia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Periodic Limb Movement Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Petit Mal Epilepsy | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Postictal Headache | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Psychomotor Skills Impaired | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Seizure Cluster | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Syncope | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Tension Headache | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Vascular Parkinsonism | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Visual Field Defect | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Psychiatric disorders | ||||
| Depression | 13/511 (2.5%) | 13 | 20/493 (4.1%) | 23 |
| Insomnia | 13/511 (2.5%) | 14 | 15/493 (3%) | 15 |
| Aggression | 8/511 (1.6%) | 8 | 20/493 (4.1%) | 20 |
| Anxiety | 8/511 (1.6%) | 9 | 6/493 (1.2%) | 6 |
| Sleep Disorder | 6/511 (1.2%) | 6 | 11/493 (2.2%) | 12 |
| Restlessness | 5/511 (1%) | 5 | 4/493 (0.8%) | 4 |
| Depressed Mood | 4/511 (0.8%) | 4 | 5/493 (1%) | 5 |
| Abnormal Behaviour | 3/511 (0.6%) | 3 | 0/493 (0%) | 0 |
| Agitation | 3/511 (0.6%) | 3 | 3/493 (0.6%) | 3 |
| Confusional State | 3/511 (0.6%) | 3 | 6/493 (1.2%) | 6 |
| Mood Altered | 3/511 (0.6%) | 3 | 3/493 (0.6%) | 3 |
| Affect Lability | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Bradyphrenia | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Mood Swings | 2/511 (0.4%) | 2 | 8/493 (1.6%) | 9 |
| Nightmare | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Personality Disorder | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Abnormal Dreams | 1/511 (0.2%) | 2 | 0/493 (0%) | 0 |
| Affective Disorder | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Apathy | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Drepressive Symptom | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Disorientation | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Dyssomnia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dysthymic Disorder | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Hallucination | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Impaired Reasoning | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Listless | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Loss of Libido | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Mental Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Nervousness | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Nocturnal Fear | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Reading Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Somatoform Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Stress | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Suicidal Ideation | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| TIC | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Anxiety Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Decreased Activity | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Emotional Disorder | 0/511 (0%) | 0 | 4/493 (0.8%) | 4 |
| Food Aversion | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Initial Insomnia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Libido Decreased | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Major Depression | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Mania | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Panic Attack | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Panic Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Paranoia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Postictal Psychosis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Psychotic Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Renal and urinary disorders | ||||
| Pollakiuria | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Polyuria | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Chromaturia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Micturition Frequency Decreased | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Micturition Urgency | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Urinary Incontinence | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Reproductive system and breast disorders | ||||
| Dysmenorrhoea | 1/511 (0.2%) | 3 | 0/493 (0%) | 0 |
| Gynaecomastia | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Menorrhagia | 1/511 (0.2%) | 1 | 1/493 (0.2%) | 1 |
| Menstrual Disorder | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Ovarian Cyst | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Amenorrhoea | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Erectile Dysfunction | 0/511 (0%) | 0 | 3/493 (0.6%) | 3 |
| Menopausal Disorder | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 2/511 (0.4%) | 2 | 4/493 (0.8%) | 4 |
| Oropharyngeal Pain | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Cough | 1/511 (0.2%) | 1 | 2/493 (0.4%) | 2 |
| Epistaxis | 1/511 (0.2%) | 2 | 0/493 (0%) | 0 |
| Throat Irritation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Asthma | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Dysphonia | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Painful Respiration | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 11/511 (2.2%) | 12 | 5/493 (1%) | 5 |
| Rash | 8/511 (1.6%) | 8 | 10/493 (2%) | 11 |
| Alopecia | 4/511 (0.8%) | 4 | 2/493 (0.4%) | 2 |
| Erythema | 3/511 (0.6%) | 3 | 0/493 (0%) | 0 |
| Hyperhidrosis | 3/511 (0.6%) | 3 | 1/493 (0.2%) | 1 |
| Dry Skin | 2/511 (0.4%) | 2 | 0/493 (0%) | 0 |
| Acne | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Hyperkeratosis | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Psoriasis | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Swelling Face | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Dermatitis | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Eczema | 0/511 (0%) | 0 | 5/493 (1%) | 6 |
| Heat Rash | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Rash Generalized | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Rash Maculo-Papular | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Rash Pruritic | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
| Skin Reaction | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Urticaria | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Surgical and medical procedures | ||||
| Amygdalohippocampectomy | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Brain Operation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Cholecystectomy | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Drug Therapy Changed | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Intervertebral Disc Operation | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Tooth Extraction | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Uterine Dilation and Curettage | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Knee Operation | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Vagal Nerve Stimulator Implantation | 0/511 (0%) | 0 | 1/493 (0.2%) | 1 |
| Vascular disorders | ||||
| Hypertension | 5/511 (1%) | 5 | 3/493 (0.6%) | 3 |
| Hot Flush | 2/511 (0.4%) | 2 | 1/493 (0.2%) | 1 |
| Circulatory Collapse | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Haematoma | 1/511 (0.2%) | 1 | 4/493 (0.8%) | 4 |
| Venous Thrombosis | 1/511 (0.2%) | 1 | 0/493 (0%) | 0 |
| Peripheral Coldness | 0/511 (0%) | 0 | 2/493 (0.4%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | UCB Clinical Trial Call Center |
|---|---|
| Organization | UCB |
| Phone | +1 877 822 9493 |
Responsible Party:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00771927
Other Study ID Numbers:
- SP0942
First Posted:
Oct 15, 2008
Last Update Posted:
Oct 27, 2014
Last Verified:
May 1, 2013