NCT00152451
Completed
Phase 2
An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs
UCB S.A. - Pharma Sector7 sites in 1 country31 target enrollmentStarted: May 19, 2005Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- UCB S.A. - Pharma Sector
- Enrollment
- 31
- Locations
- 7
- Primary Endpoint
- Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period
Overview
Brief Summary
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
- •Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
- •Subjects who have been treated for epilepsy for \>=6 months and are currently uncontrolled while being treated with 1-3 concomitant Antiepileptic Drug (AEDs)
- •Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion Criteria
- •Seizures occurring in clusters.
- •Status epilepticus within 6 months of Visit 1
- •History of non-epileptic seizures
- •Subjects on vigabatrin
- •Subjects on felbamate, unless treatment has been continuous for \>2 years
- •Ongoing psychiatric disease other than mild controlled disorders.
- •Subjects with clinically significant organ dysfunction
- •Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- •Pregnant or lactating women
- •Subjects currently taking levetiracetam (LEV)
Arms & Interventions
Seletracetam
Experimental
Escalating doses twice daily were to be administered.
Intervention: Seletracetam (ucb 44212) (Drug)
Outcomes
Primary Outcomes
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period
Time Frame: During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Secondary Outcomes
- Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period(During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4))
- Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period(During the Up-Titration Period (Week 5 to Week 12))
- Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period(During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period(Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4))
- Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)(During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period(During the Down-Titration Period (Week 13 to Week 15))
- Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period(During the Treatment Period (Week 5 to Week 15))
- Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period(Week 12, compared to Baseline Period (Week 1 to Week 4))
- Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period(Week 12, compared to Baseline Period (Week 1 to Week 4))
- Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period(Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4))
- Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period(Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4))
- Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)(Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4))
- Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period(During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period(During the Treatment Period (Week 5 to Week 15))
- Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period(During the Treatment Period (Week 5 to Week 15))
- Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period(Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4))
- Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)(During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period(During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4))
- Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period(During the Treatment Period (Week 5 to Week 15))
- Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period(During the Up-Titration Period (Week 5 to Week 12))
- Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period(During the Down-Titration Period (Week 13 to Week 15))
- Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)(Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4))
Investigators
Study Sites (7)
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