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

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Placebo; Drug: Keppra® extended release formulation - XR

• Registration Number: NCT00368069
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-23
• Study First Posted: 2006-08-24
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Results First Submitted: 2009-04-01
• Results First Submitted QC: 2009-06-05
• Results First Posted: 2009-07-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Keppra® XR	Keppra® extended release formulation - XR	Keppra® extended release formulation -XR

Primary Outcome Measures

Name	Time	Method
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population	Treatment period (12 weeks)	Number of POS over the treatment period standardized to 1 week period.
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population	Treatment Period (12 weeks)	Number of POS over the treatment period standardized to 1 week period

Secondary Outcome Measures

Name	Time	Method
POS Seizure Frequency Per Week Over Baseline and Treatment Period	Baseline Period (8 weeks) - Treatment Period (12 weeks)
All (Type I+II+III) Seizures Frequency Per Week	Treatment period (12 weeks)	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)
50% Response in Weekly POS Frequency	Treatment period (12 weeks)	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.
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks	over the treatment period (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.

Trial Locations

Locations (34)

N01235 1007; 🇧🇷 Curitiba, Brazil

N01235 2001; 🇫🇮 Kuopio, Finland

N01235 2003; 🇫🇮 Tampere, Finland

N01235 2002; 🇫🇮 Turku, Finland

N01235 3008; 🇮🇳 Chennai, India

N01235 3010; 🇮🇳 Chennai, India

N01235 3012; 🇮🇳 Ghandinagar, India

N01235 3003; 🇮🇳 Hyderabad, India

N01235 3004; 🇮🇳 Hyderabad, India

N01235 3001; 🇮🇳 Lucknow, India

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