SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00136019

Purpose

Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about five months.

Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks.

The study clinic visits will include a medical history and physical exam, electrocardiogram (ECG), blood and urine sample collection, and completion of a seizure diary.

Patients who complete the study may enroll in an extension trial and receive active study drug.

Condition	Intervention	Phase
Epilepsy	Drug: SPM 927	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Efficacy is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status.

Secondary Outcome Measures:

Safety of lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data.

Estimated Enrollment:	400
Study Start Date:	March 2004
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Epilepsy with partial seizures

Exclusion Criteria:

Subject received SPM 927 in a previous trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136019

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SP754
Study First Received:	August 24, 2005
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00136019 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Epilepsy with partial seizures

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 20, 2009