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NCT00422110 Clinical Trial

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

Epilepsies, Partial Clinical Trial

Official title:
A Phase IIb/III, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Seletracetam as Adjunctive Treatment in Subjects (≥16 to 70 Years Old) With Refractory Partial Onset Seizures.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00422110
Other study ID # N01272
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received January 11, 2007
Last updated May 25, 2012
Start date May 2008

Study information
Verified date May 2012
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Seletracetam

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)
See also
  Status Clinical Trial Phase
Terminated NCT00524030 - Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures Phase 3
Completed NCT00143143 - Pregabalin Open-Label Extension Trial in Patients With Partial Seizures Phase 3
Completed NCT00771927 - Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures N/A
Completed NCT00236873 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures. Phase 2
Completed NCT01745952 - Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS) N/A
Completed NCT00772603 - Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures Phase 3
Completed NCT00280696 - A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures Phase 3
Completed NCT00643136 - A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures Phase 3
Completed NCT00230698 - A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure Phase 3
Completed NCT00072813 - MRI in Autosomal Dominant Partial Epilepsy With Auditory Features N/A
Enrolling by invitation NCT04309812 - Transcranial Direct Current to Treat Epilepsy at Home Early Phase 1
Completed NCT00620555 - A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures Phase 3
Completed NCT00448916 - Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures Phase 3
Completed NCT00210522 - An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy Phase 2
Completed NCT00236886 - Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients Phase 3
Completed NCT00236860 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures Phase 2
Active, not recruiting NCT03689114 - Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) Phase 4
Completed NCT01098162 - Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug N/A
Completed NCT05273398 - Effects of Diazepam on RNS Detections Phase 4
Completed NCT00918047 - Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients Phase 1