Phase 2
N=31
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
Epilepsy, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00152451 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period — -30.88 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Seletracetam (ucb 44212) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB S.A. - Pharma Sector
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period |
-30.88 | — |
| SECONDARY 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) |
-40.06; -37.50; -27.68; -39.88; -39.33; -41.67 | — |
| SECONDARY Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period |
-36.36 | — |
| SECONDARY 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) |
-40.06; -37.50; -27.68; -39.88; -39.33; -41.67 | — |
| SECONDARY Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period |
-30.88 | — |
| SECONDARY Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period |
-36.36 | — |
| SECONDARY Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period |
2.50; 3.73; 2.55; 2.50; 3.00; 4.00 | — |
| SECONDARY Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period |
2.74 | — |
| SECONDARY Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period |
2.25 | — |
| SECONDARY Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period |
3.50 | — |
| SECONDARY Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period |
2.50; 3.73; 2.55; 2.50; 3.00; 4.00 | — |
| SECONDARY Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period |
2.74 | — |
| SECONDARY Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period |
2.25 | — |
| SECONDARY Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period |
3.50 | — |
| SECONDARY Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period |
25.8 | — |
| SECONDARY Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period |
3.2; 35.5; 51.6; 3.2; 6.5 | — |
| SECONDARY Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period |
13.80 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period |
-0.96 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period |
-1.14 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period |
-0.96 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period |
-1.14 | — |
| SECONDARY Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration) |
-1.25; -1.39; -1.25; -1.94; -1.60; -1.25 | — |
| SECONDARY 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) |
-1.25; -1.39; -1.25; -1.94; -1.60; -1.25 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00152451). 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.