A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
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| ClinicalTrials.gov Identifier: NCT01710657 |
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Recruitment Status :
Completed
First Posted : October 19, 2012
Results First Posted : February 9, 2015
Last Update Posted : August 25, 2017
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Sponsor:
UCB Pharma SA
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy Partial Onset Seizures | Drug: Lacosamide 50 mg Drug: Lacosamide 100 mg Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 548 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | July 2014 |
| Actual Study Completion Date : | August 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Seizures
Drug Information available for:
Lacosamide
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Matching placebo for 16 weeks.
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Drug: Placebo
Matching oral Placebo tablets twice daily for 16 weeks. |
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Experimental: Lacosamide 200 mg/day
Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
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Drug: Lacosamide 50 mg
Other Name: Vimpat Drug: Lacosamide 100 mg
Other Name: Vimpat |
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Experimental: Lacosamide 400 mg/day
Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
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Drug: Lacosamide 50 mg
Other Name: Vimpat Drug: Lacosamide 100 mg
Other Name: Vimpat |
Primary Outcome Measures :
- Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period [ Time Frame: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8) ]
Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
Secondary Outcome Measures :
- The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate) [ Time Frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) ]
- Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period [ Time Frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) ]Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
- Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period) [ Time Frame: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8) ]
Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.
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| Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
- Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
- Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
- Minimum Body Weight of 40 kg
Exclusion Criteria:
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
- Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
- Subject has a history of Primary Generalized Seizures
- Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
- Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
- Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Information from the National Library of Medicine
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): NCT01710657
Locations
Show 76 study locations
Sponsors and Collaborators
UCB Pharma SA
UCB Japan Co. Ltd.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | UCB Pharma SA |
| ClinicalTrials.gov Identifier: | NCT01710657 |
| Other Study ID Numbers: |
EP0008 2014-003622-41 ( EudraCT Number ) JapicCTI-121988 ( Registry Identifier: JAPIC ) |
| First Posted: | October 19, 2012 Key Record Dates |
| Results First Posted: | February 9, 2015 |
| Last Update Posted: | August 25, 2017 |
| Last Verified: | July 2017 |
Keywords provided by UCB Pharma ( UCB Pharma SA ):
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Lacosamide Epilepsy Partial Onset Seizures |
Additional relevant MeSH terms:
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Epilepsy Seizures 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 |