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OpenTrials
Completed

NCT Number: NCT00522275

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

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

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Key information

Conditions

Partial Epilepsies Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lacosamide

Drug

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

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

    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 (Maximum 6 Years)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2007
Registry last updated
Jul 18, 2018

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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