Phase 2 Completed N=31 Treatment

Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

Epilepsy, Partial

Source: ClinicalTrials.gov NCT00152451 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcomePrimary: 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

Summary

This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

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	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.