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
|ClinicalTrials.gov Identifier: NCT00220415|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2014
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 or disease||Intervention/treatment||Phase|
|Partial Seizures With or Without Secondary Generalization||Drug: SPM 927||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||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|
|Study Start Date :||May 2004|
|Primary Completion Date :||January 2006|
|Study Completion Date :||January 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220415
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|