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

NCT00152503 | Completed Phase 2 Results FDA Drug

• 1 other identifier: N01192
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 17

Brief Summary

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

Conditions

Epilepsy, Partial

Keywords

Epilepsy; Partial Onset Seizures; Seletracetam; Levetiracetam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period

  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

  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

  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

  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

  During the Treatment Period (Week 5 to Week 15)

Study Arms (1)

Seletracetam

EXPERIMENTAL

Escalating doses twice daily were to be administered.

Drug: Seletracetam (UCB44212)

Interventions

Seletracetam (UCB44212) DRUG

* Pharmaceutical form: oral capsules * Concentration: 2, 10 and 50 mg * Route of administration: oral administration

Seletracetam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (17)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Chesterfield, Missouri, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Calgary, Canada

Location

Unknown Facility

Montreal, Canada

Location

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Seletracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  UCB (+1 844 599 2273)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: August 31, 2005
• Primary Completion: May 12, 2006
• Study Completion: May 12, 2006
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2022-10

Locations

CA (3); US (14)