NCT00422110
Withdrawn
Phase 2
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.
ConditionsEpilepsies, Partial
DrugsSeletracetam
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- UCB Pharma
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)
Investigators
Similar Trials
Withdrawn
Phase 3
Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.EpilepsyNCT00175864UCB Pharma
Completed
Phase 3
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary GeneralizationEpilepsyPartial SeizuresNCT01392768Ache Laboratorios Farmaceuticos S.A.126
Completed
Not Applicable
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in PediatricsAllergic RhinoconjunctivitisNCT03365648NTC srl150
Withdrawn
Phase 3
Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of EpilepsyEpilepsyNCT00175851UCB Pharma
Terminated
Phase 3
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant TherapyDepressive Disorder, MajorNCT04532749Janssen Research & Development, LLC212