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
Overview
- Phase
- Phase 3
- Intervention
- Lacosamide
- Conditions
- Epilepsy
- Sponsor
- UCB Pharma SA
- Enrollment
- 473
- Locations
- 67
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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]
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has completed the Treatment and Transition Period of EP0008 \[NCT01710657\]
Exclusion Criteria
- •Subjects who withdrew from EP0008 \[NCT01710657\]
Arms & Interventions
Lacosamide
Lacosamide treatment of 100 - 400 mg/day for long-term
Intervention: Lacosamide
Outcomes
Primary Outcomes
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 Outcomes
- 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(From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009)
- 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(From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009)