Trial record 1 of 2 for:
NCT01832038
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
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| ClinicalTrials.gov Identifier: NCT01832038 |
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Recruitment Status :
Completed
First Posted : April 15, 2013
Results First Posted : August 13, 2020
Last Update Posted : December 17, 2020
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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 trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy Partial-onset Seizures | Drug: Lacosamide | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 473 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization |
| Actual Study Start Date : | March 26, 2013 |
| Actual Primary Completion Date : | July 31, 2019 |
| Actual Study Completion Date : | July 31, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lacosamide
Lacosamide treatment of 100 - 400 mg/day for long-term
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Drug: Lacosamide
Strength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day. Other Name: Vimpat |
Primary Outcome Measures :
- Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit [ Time Frame: From Visit 1 (Week 0) up to approximately Week 323 ]An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit [ Time Frame: From Visit 1 (Week 0) up to approximately Week 323 ]An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Secondary Outcome Measures :
- Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 [ Time Frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 ]The percent change from Baseline to the Treatment Period was calculated as {[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].
- Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 [ Time Frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 ]A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 completed the Treatment and Transition Period of EP0008 [NCT01710657]
Exclusion Criteria:
- Subjects who withdrew from EP0008 [NCT01710657]
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): NCT01832038
Locations
Show 67 study locations
Sponsors and Collaborators
UCB Pharma SA
UCB Japan Co. Ltd.
Investigators
| Study Director: | UCB Cares | +1 844 599 2273 (UCB) |
Study Documents (Full-Text)
Documents provided by UCB Pharma ( UCB Pharma SA ):
Documents provided by UCB Pharma ( UCB Pharma SA ):
Study Protocol [PDF] March 13, 2013
Statistical Analysis Plan [PDF] September 12, 2014
Additional Information:
| Responsible Party: | UCB Pharma SA |
| ClinicalTrials.gov Identifier: | NCT01832038 |
| Other Study ID Numbers: |
EP0009 |
| First Posted: | April 15, 2013 Key Record Dates |
| Results First Posted: | August 13, 2020 |
| Last Update Posted: | December 17, 2020 |
| Last Verified: | November 2020 |
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 |