Phase 3
Completed N=473
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Source: ClinicalTrials.gov NCT01832038 ↗Enrolled (actual)
473
Serious AEs
17.5%
Results posted
Aug 2020
Primary outcomePrimary: 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 — 410 Participants
◆ Published Evidence
Established
24citations · ~5 / year
Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial.
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]
Linked Publications
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Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
410 | — |
| PRIMARY Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit |
51 | — |
| SECONDARY 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 |
-44.47 | — |
| SECONDARY 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 |
57.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]
Exclusion Criteria
- Subjects who withdrew from EP0008 [NCT01710657]
Data sourced from ClinicalTrials.gov (NCT01832038) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.