Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

UCB BIOSCIENCES, Inc.308 enrolled

Overview

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

308

Conditions

Partial Epilepsies

Interventions

lacosamideDRUG

50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completion of parent clinical trial for treatment of partial seizures Exclusion Criteria: * Receiving any study drug or experimental device other than lacosamide * Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event

Locations (60)

Outcomes

Primary Outcomes

Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame: During the Treatment Period (Maximum 6 years)

Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame: During the Treatment Period (Maximum 6 years)

Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)

Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame: During the Treatment Period (Maximum 6 years)

Secondary Outcomes

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)

Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

Time frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)

Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)

At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.

Time frame: Treatment Period (Maximum 6 years)

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Englewood, Colorado, United States

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Fairfield, Connecticut, United States

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Bradenton, Florida, United States

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Jacksonville, Florida, United States

...and 50 more locations