Clinical trial NCT00152451: Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy, Partial
Keywords: Epilepsy
Partial onset seizures
Seletracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the efficacy and safety of ucb 44212 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 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)
* 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: Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period
timeFrame: During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Secondary outcomes:
measure: 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)
timeFrame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
timeFrame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: 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)
timeFrame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in 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: Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period
timeFrame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
measure: Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
timeFrame: During the Treatment Period (Week 5 to Week 15)
measure: Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period
timeFrame: During the Treatment Period (Week 5 to Week 15)
measure: Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period
timeFrame: During the Up-Titration Period (Week 5 to Week 12)
measure: Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period
timeFrame: During the Down-Titration Period (Week 13 to Week 15)
measure: Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
timeFrame: During the Treatment Period (Week 5 to Week 15)
measure: Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period
timeFrame: During the Treatment Period (Week 5 to Week 15)
measure: Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period
timeFrame: During the Up-Titration Period (Week 5 to Week 12)
measure: Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period
timeFrame: During the Down-Titration Period (Week 13 to Week 15)
measure: Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period
timeFrame: Week 12, compared to Baseline Period (Week 1 to Week 4)
measure: Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
timeFrame: Week 12, compared to Baseline Period (Week 1 to Week 4)
measure: Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
timeFrame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
measure: Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
timeFrame: During the Down-Titration Period (Week 13 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) During the Up-titration Period
timeFrame: Week 5 to Week 12, 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) Overall in the Down-titration Period
timeFrame: Week 13 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) Overall in the Up-titration Period
timeFrame: Week 5 to Week 12, 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 Over the Treatment Period (Up-titration + Down-titration)
timeFrame: 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 Over the Treatment Period (Up-titration + Down-titration)
timeFrame: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: N01191 108
state: Arkansas
city: San Francisco
country: United States
facility: N01191 105
state: California
city: Stanford
country: United States
facility: N01191 102
state: California
city: Columbus
country: United States
facility: N01191 107
state: Ohio
city: Philadelphia
country: United States
facility: N01191 104
state: Pennsylvania
city: Nashville
country: United States
facility: N01191 101
state: Tennessee
city: Charlottesville
country: United States
facility: N01191 103
state: Virginia
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References: