A Study to Evaluate the Efficacy and Safety of Seletracet... | NCT00422110

Studies
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

NCT00422110

Sponsor

UCB Pharma

Status

Withdrawn

Last Update Posted

May 28, 2012Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Epilepsies, Partial

Interventions

Seletracetam

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 11, 2007

First Submission Date that Met QC Criteria

Jan 11, 2007

First Posted Date

Jan 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2012

Last Update Posted Date

May 28, 2012Estimated

Description Module

Brief Summary

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Seletracetam	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs

Secondary Outcomes

Measure	Description	Time Frame
Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects from 16 to 70 years old
Confirmed diagnosis of focal epilepsy
Partial seizures uncontrolled while taking 1 or 2 AEDs
At least 8 partial seizures during the 8-week baseline period

Exclusion Criteria:

Seizures occurring only in clusters
Status epilepticus within 1 year
Progressive CNS disorder
Other serious or uncontrolled diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Barbara Bennett, PhD	UCB Pharma	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D004828	Epilepsies, Partial
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C518915	Seletracetam

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided