Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy, Partial
• Intervention / Treatment: Drug: Seletracetam (UCB44212)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada
  • Montreal, Canada
  • Alberta
    • Edmonton, Alberta, Canada
• United States
  • Arizona
    • Phoenix, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • Florida
    • Saint Petersburg, Florida, United States
  • Illinois
    • Springfield, Illinois, United States
  • Kansas
    • Wichita, Kansas, United States
  • Michigan
    • Detroit, Michigan, United States
  • Missouri
    • Chesterfield, Missouri, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Columbus, Ohio, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
  • Virginia
    • Charlottesville, Virginia, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seletracetam; Escalating doses twice daily were to be administered.	Drug: Seletracetam (UCB44212); Pharmaceutical form: oral capsules; Concentration: 2, 10 and 50 mg; Route of administration: oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period	Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.	During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period	Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.	During the Treatment Period (Week 5 to Week 15)
Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period	A responder was defined as a subject with a >= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period	Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: <-25%, -25% to <25%, 25% to <75%, and 75% to 100%.	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period	A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

Collaborators and Investigators

• Sponsor: UCB Pharma SA
• Investigators: Study Director: UCB Cares, UCB (+1 844 599 2273)

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2005
• Primary Completion (Actual): May 12, 2006
• Study Completion (Actual): May 12, 2006

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimated): September 9, 2005

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Partial Onset Seizures; Levetiracetam; Seletracetam
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial
• Other Study ID Numbers: N01192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No