A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

Epilepsy Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368069
• Other study ID #: N01235
• Secondary ID: 2006-000987-10
• Status: Completed
• Phase: Phase 3
• Start date: August 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of refractory epilepsy

• Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)

• Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion Criteria:

• Seizures occurring in clusters

• Status epilepticus within 3 months of Visit 1

• History of non-epileptic seizures

• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

• Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily
• Placebo
oral tablets, 2 tablets once daily

Locations

Country	Name	City	State
Brazil	N01235 1007	Curitiba
Finland	N01235 2001	Kuopio
Finland	N01235 2003	Tampere
Finland	N01235 2002	Turku
India	N01235 3008	Chennai
India	N01235 3010	Chennai
India	N01235 3012	Ghandinagar
India	N01235 3003	Hyderabad
India	N01235 3004	Hyderabad
India	N01235 3001	Lucknow
India	N01235 3009	Madurai
India	N01235 3002	Mumbai
India	N01235 3007	Mumbai
India	N01235 3011	Visakhapatnam
Mexico	N01235 4006	Aguascalientes
Mexico	N01235 4003	Distrio Federal
Mexico	N01235 4001	Guadalajara
Mexico	N01235 4005	Puebla
Russian Federation	N01235 5001	Moscow
Russian Federation	N01235 5002	Moscow
Russian Federation	N01235 5003	Moscow
Russian Federation	N01235 5005	Moscow
Russian Federation	N01235 5006	Moscow
Russian Federation	N01235 5007	Moscow
Russian Federation	N01235 5004	Saint Petersburg
Russian Federation	N01235 5009	Saint Petersburg
Russian Federation	N01235 5008	Smolensk
South Africa	N01235 6002	Cape Town
South Africa	N01235 6003	Umhlanga
Ukraine	N01235 7001	Kharkov
Ukraine	N01235 7004	Kharkov
Ukraine	N01235 7005	Lviv
Ukraine	N01235 7002	Odessa
Ukraine	N01235 7003	Poltava

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Brazil,  Finland,  India,  Mexico,  Russian Federation,  South Africa,  Ukraine, 

References & Publications (2)

Peltola J, Coetzee C, Jiménez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a dou — View Citation

Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population	Number of POS over the treatment period standardized to 1 week period.	Treatment period (12 weeks)
Primary	Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population	Number of POS over the treatment period standardized to 1 week period	Treatment Period (12 weeks)
Secondary	POS Seizure Frequency Per Week Over Baseline and Treatment Period		Baseline Period (8 weeks) - Treatment Period (12 weeks)
Secondary	All (Type I+II+III) Seizures Frequency Per Week	Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)	Treatment period (12 weeks)
Secondary	50% Response in Weekly POS Frequency	A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.	Treatment period (12 weeks)
Secondary	Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks	The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.	over the treatment period (12 weeks)

External Links

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