A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

This study has been completed.

First Received: August 30, 2005 Last Updated: March 7, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00220415

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 this research study at approximately 80 different locations in Australia and Europe.

The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.

Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks.

The study clinic visits will include a medical history and physical exam, 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
Partial Seizures With or Without Secondary Generalization	Drug: SPM 927	Phase III

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

MedlinePlus related topics: Seizures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Further study details as provided by UCB:

Study Start Date:	May 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 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:

partial seizures with or without secondary generalization

Exclusion Criteria:

subjects received SPM 927 in a previous trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220415

Locations

Germany
Schwarz
Monheim, Germany

Sponsors and Collaborators

UCB

Investigators

Study Director:

Bengt Hoepken

UCB

More Information

No publications provided

Study ID Numbers:	SP755
Study First Received:	August 30, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00220415 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Signs and Symptoms
Epilepsy
Seizures
Neoplasm Metastasis

Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplastic Processes
Pathologic Processes
Epilepsy
Nervous System Diseases

Seizures
Neoplasm Metastasis
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 06, 2009