Phase 2
N=59
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Epilepsy, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00152503 ↗Enrolled (actual)
59
Serious AEs
3.4%
Results posted
Sep 2023
Primary outcome: Primary: Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period — -26.07; -32.05; -42.22; -31.67 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Seletracetam (UCB44212) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma SA
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period |
-26.07; -32.05; -42.22; -31.67; -34.01; -44.44 | — |
| SECONDARY Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period |
-26.07; -32.05; -42.22; -31.67; -34.01; -44.44 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period |
-0.85; -1.25; -1.83; -1.31; -1.36; -1.68 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period |
-0.85; -1.25; -1.83; -1.31; -1.36; -1.68 | — |
| SECONDARY Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period |
3.63; 3.25; 2.90; 2.15; 2.27; 2.71 | — |
| SECONDARY Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period |
3.63; 3.25; 2.90; 2.15; 2.27; 2.71 | — |
| SECONDARY Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period |
28.6 | — |
| SECONDARY Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period |
12.5; 25.0; 57.1; 5.4 | — |
| SECONDARY Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period |
11.45 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00152503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.