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

Epilepsy, Partial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152451
• Other study ID #: N01191
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2005
• Est. completion date: May 3, 2006

Study information

• Verified date: September 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 3, 2006
• Est. primary completion date: May 3, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Partial
• Seizures

Intervention

Drug:
• Seletracetam (ucb 44212)
Pharmaceutical form: oral capsules Concentration: 10 and 50 mg Route of administration: oral administration

Locations

Country	Name	City	State
United States	N01191 103	Charlottesville	Virginia
United States	N01191 107	Columbus	Ohio
United States	N01191 108	Little Rock	Arkansas
United States	N01191 101	Nashville	Tennessee
United States	N01191 104	Philadelphia	Pennsylvania
United States	N01191 105	San Francisco	California
United States	N01191 102	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
UCB S.A. - Pharma Sector

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period	Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).	During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
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)	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	Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period	Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).	During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
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)	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)
Secondary	Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period	Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Secondary	Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period	Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).	During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Secondary	Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment 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)
Secondary	Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment 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).	During the Treatment Period (Week 5 to Week 15)
Secondary	Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period	Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).	During the Up-Titration Period (Week 5 to Week 12)
Secondary	Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period	Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).	During the Down-Titration Period (Week 13 to Week 15)
Secondary	Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment 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)
Secondary	Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment 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).	During the Treatment Period (Week 5 to Week 15)
Secondary	Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period	Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).	During the Up-Titration Period (Week 5 to Week 12)
Secondary	Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period	Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).	During the Down-Titration Period (Week 13 to Week 15)
Secondary	Responder Rate 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.	Week 12, compared to Baseline Period (Week 1 to Week 4)
Secondary	Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period	Categories of percentage change in seizures from Baseline were as following: < -25%; -25% to <25%; 25% to <75%; 75% to <100%; 100%.	Week 12, compared to Baseline Period (Week 1 to Week 4)
Secondary	Percentage 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.	Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
Secondary	Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period	Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).	During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Secondary	Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period	Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).	Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
Secondary	Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period	Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).	Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4)
Secondary	Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period	Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).	Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
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)	Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall 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).	Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)
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)	Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall 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).	Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)