Phase 3 Completed N=473 Treatment

Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

Epilepsy · 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

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]

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]

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01832038). 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.