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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 - Article


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Seizures

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Clinical Trial: 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

This study is currently recruiting patients.
Verified by Schwarz Pharma August 2005

Sponsored by: Schwarz Pharma
Information provided by: Schwarz Pharma
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 study drug (lacosamide) 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, 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 with partial seizures
 Drug: SPM 927
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: 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 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects with Partial Seizures with or Without Secondary Generalization.

Eligibility

Ages Eligible for Study:  16 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • epilepsy with partial seizures

Exclusion Criteria:

  • subject received SPM 927 in a previous trial

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136019

Margaret Richardson       margaret.richardson@schwarzbiosciences.com

North Carolina
      Schwarz, RTP,  North Carolina,  27709,  United States; Recruiting
Margaret Richardson

More Information

Study ID Numbers:  SP754
Last Updated:  August 25, 2005
Record first received:  August 24, 2005
ClinicalTrials.gov Identifier:  NCT00136019
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30


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September 5, 2008



Page Updated: December 9, 2005
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