Trial record 1 of 1 for:    NCT00220415
Previous Study | Return to List | Next Study

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.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00220415
First received: August 30, 2005
Last updated: September 19, 2014
Last verified: February 2010

August 30, 2005
September 19, 2014
May 2004
January 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00220415 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Partial Seizures With or Without Secondary Generalization
Drug: SPM 927
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2006
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • partial seizures with or without secondary generalization

Exclusion Criteria:

  • subjects received SPM 927 in a previous trial
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00220415
SP0755, 2004-000290-58
Not Provided
Not Provided
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP