A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
- Conditions
- Epilepsy
- Interventions
- Drug: Placebo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- 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
- 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 2002
🇫🇮Turku, Finland
N01235 3010
🇮🇳Chennai, India
N01235 3012
🇮🇳Ghandinagar, India
N01235 3003
🇮🇳Hyderabad, India
N01235 3002
🇮🇳Mumbai, India
N01235 3009
🇮🇳Madurai, India
N01235 3007
🇮🇳Mumbai, India
N01235 3011
🇮🇳Visakhapatnam, India
N01235 4003
🇲🇽Distrio Federal, Mexico
N01235 5005
🇷🇺Moscow, Russian Federation
N01235 5003
🇷🇺Moscow, Russian Federation
N01235 5006
🇷🇺Moscow, Russian Federation
N01235 5007
🇷🇺Moscow, Russian Federation
N01235 5008
🇷🇺Smolensk, Russian Federation
N01235 7001
🇺🇦Kharkov, Ukraine
N01235 6003
🇿🇦Umhlanga, South Africa
N01235 6002
🇿🇦Cape Town, South Africa
N01235 7004
🇺🇦Kharkov, Ukraine
N01235 7005
🇺🇦Lviv, Ukraine
N01235 7002
🇺🇦Odessa, Ukraine
N01235 7003
🇺🇦Poltava, Ukraine
N01235 3004
🇮🇳Hyderabad, India
N01235 4005
🇲🇽Puebla, Mexico
N01235 4006
🇲🇽Aguascalientes, Mexico
N01235 5009
🇷🇺Saint Petersburg, Russian Federation
N01235 2003
🇫🇮Tampere, Finland
N01235 2001
🇫🇮Kuopio, Finland
N01235 4001
🇲🇽Guadalajara, Mexico
N01235 5002
🇷🇺Moscow, Russian Federation
N01235 3008
🇮🇳Chennai, India
N01235 3001
🇮🇳Lucknow, India
N01235 5004
🇷🇺Saint Petersburg, Russian Federation
N01235 5001
🇷🇺Moscow, Russian Federation