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

NCT00152451 | Completed Phase 2 Results FDA Drug

• 1 other identifier: N01191
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Epilepsy, Partial

Keywords

Epilepsy; Partial onset seizures; Seletracetam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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)

  During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

• Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period

  During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)

• 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)

  During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

• Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period

  During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

• Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period

  During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)

Study Arms (1)

Seletracetam

EXPERIMENTAL

Escalating doses twice daily were to be administered.

Drug: Seletracetam (ucb 44212)

Interventions

Seletracetam (ucb 44212) DRUG

* Pharmaceutical form: oral capsules * Concentration: 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 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

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
• 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)

Sponsors & Collaborators

• UCB S.A. - Pharma Sector: lead

Study Sites (7)

N01191 108

Little Rock, Arkansas, 72205, United States

Location

N01191 105

San Francisco, California, 94115, United States

Location

N01191 102

Stanford, California, 94305, United States

Location

N01191 107

Columbus, Ohio, 43210, United States

Location

N01191 104

Philadelphia, Pennsylvania, 19104, United States

Location

N01191 101

Nashville, Tennessee, 37212, United States

Location

N01191 103

Charlottesville, Virginia, 22903, United States

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: NA
• 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: May 19, 2005
• Primary Completion: May 3, 2006
• Study Completion: May 3, 2006
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)