Clinical trial NCT00152503: Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Official title: An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy, Partial
Keywords: Epilepsy
Partial Onset Seizures
Seletracetam
Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.


Eligibility criteria: 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 AED(s), inclusive of levetiracetam (LEV)
* Female subjects without childbearing potential or those who are using an acceptable 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
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).

Primary outcomes:
measure: Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
timeFrame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Secondary outcomes:
measure: Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
timeFrame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
timeFrame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
timeFrame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
timeFrame: During the Treatment Period (Week 5 to Week 15)
measure: Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
timeFrame: During the Treatment Period (Week 5 to Week 15)
measure: Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period
timeFrame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
measure: Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
timeFrame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
measure: Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
timeFrame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Saint Petersburg
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Detroit
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: Calgary
country: Canada
city: Montreal
country: Canada
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References: