Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures (PASS)
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| ClinicalTrials.gov Identifier: NCT00771927 |
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Recruitment Status :
Completed
First Posted : October 15, 2008
Results First Posted : April 22, 2013
Last Update Posted : October 27, 2014
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| Condition or disease | Intervention/treatment |
|---|---|
| Epilepsies, Partial | Drug: Lacosamide |
| 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 : | October 2008 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | March 2012 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Lacosamide
Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
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Drug: Lacosamide
Vimpat was used as per site routine practices, and in-line with the marketing authorization.
Other Name: Vimpat® |
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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
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- 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 [ Time Frame: 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.
- 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771927
Show 62 study locations
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00771927 |
| Other Study ID Numbers: |
SP0942 |
| First Posted: | October 15, 2008 Key Record Dates |
| Results First Posted: | April 22, 2013 |
| Last Update Posted: | October 27, 2014 |
| Last Verified: | May 2013 |
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Vimpat® Lacosamide LCM epilepsy epilepsies seizure partial seizure partial onset seizure disorder single seizure motor seizure convulsions add-on |
AED anti-epileptic anti-epileptic drug seizure control open-label post authorization PASS late stage trial study phase 4 phase IV |
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Epilepsy Seizures Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Lacosamide Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |