Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS

Epilepsy, Partial Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152373
• Other study ID #: N01102
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: December 2, 2013
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

1. subject suffering from partial onset seizures, whether or not secondarily generalized,

2. presence of the following during the eight weeks of the historical baseline period:

at least eight partial seizures (type IA, IB or IC) with or without secondary generalization.

3. subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).

4. subject who has been exposed to at least one classical AEDs,

5. CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.

Exclusion Criteria:

1. history of status epilepticus within three months prior to the Selection visit,

2. subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),

3. use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed.,

4. history or presence of pseudoseizures,

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy, Partial

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance)
Secondary	Seizure freedom ;
Secondary	The partial onset (type I) seizure reduction response rate ;
Secondary	Safety and tolerability

External Links

•   Clinical Study Summary on UCB.com