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Completed

NCT Number: NCT00515619

Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of Epilepsy
  • completion of double blind trial

Exclusion criteria

  • taking other investigational drug than Lacosamide
  • meeting withdrawal criteria from double blind trial

Treatment and study plan

Lacosamide

Drug

50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial

Other names: SPM 927, LCM

Primary outcomes

  1. Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)

    Time frame: During the Treatment Period (up to 5.5 years)

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

  2. Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)

    Time frame: During the Treatment Period (up to 5.5 years)

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

  3. Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)

    Time frame: During the Treatment Period (up to 5.5 years)

    A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.

Secondary outcomes

  1. Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)

    Time frame: Baseline, Treatment Period (up to 5.5 years)

    Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

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

  2. Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)

    Time frame: Treatment Period (up to 5.5 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. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2007
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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