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

Phase 3

Completed

• Conditions: Epilepsy; Partial-onset Seizures
• Interventions: Drug: Lacosamide

• Registration Number: NCT01832038
• Lead Sponsor: UCB Pharma SA

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 \[NCT01710657\]

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-26
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-15
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Results First Submitted: 2020-07-28
• Results First Submitted QC: 2020-07-28
• Results First Posted: 2020-08-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

Inclusion Criteria

• Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

Exclusion Criteria

• Subjects who withdrew from EP0008 [NCT01710657]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	Lacosamide treatment of 100 - 400 mg/day for long-term

Primary Outcome Measures

Name	Time	Method
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	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	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

Name	Time	Method
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	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	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 \[NCT01710657\].

Trial Locations

Locations (67)

86026; 🇨🇳 Beijing, China

86027; 🇨🇳 Beijing, China

86015; 🇨🇳 Changchun, China

86005; 🇨🇳 Chengdu, China

86032; 🇨🇳 Chengdu, China

86006; 🇨🇳 Chongqing, China

86031; 🇨🇳 Dalian, China

86007; 🇨🇳 Guangzhou, China

86008; 🇨🇳 Guangzhou, China

86009; 🇨🇳 Guangzhou, China

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