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NCT00245713 Clinical Trial

Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.

Epilepsy, Partial Clinical Trial

Official title:
9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00245713
Other study ID # N01085
Secondary ID
Status Completed
Phase Phase 4
First received October 26, 2005
Last updated November 25, 2013
Start date March 2003
Est. completion date November 2004

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2004
Est. primary completion date November 2004
Accepts healthy volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit

- Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment

Exclusion Criteria:

- Subjects dosing with LEV two weeks prior to the selection visit

- Subjects using more than one AED

- Subjects with specific and non-specific sleep disorders

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• levetiracetam

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
Secondary Secondary endpoints are based on the changes from Baseline to visit 7
See also
  Status Clinical Trial Phase
Completed NCT00105040 - A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures Phase 2
Completed NCT00160615 - Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method Phase 3
Completed NCT00113165 - Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures Phase 3
Completed NCT00175890 - A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures. Phase 3
Completed NCT00152516 - Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures Phase 3
Withdrawn NCT01691872 - Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects Phase 1
Completed NCT00160654 - Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy Phase 4
Terminated NCT01545518 - IVIG Treatment for Refractory Immune-Related Adult Epilepsy Phase 2
Completed NCT00141414 - To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy. Phase 2
Completed NCT01332539 - An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy N/A
Completed NCT00355082 - Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy Phase 3
Completed NCT00152451 - Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures Phase 2
Withdrawn NCT02220972 - To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures Phase 4
Completed NCT00160628 - Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy Phase 3
Terminated NCT01375374 - Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide Phase 3
Completed NCT00152373 - Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS Phase 3
Completed NCT00150709 - A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy Phase 3
Completed NCT00643500 - Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4
Completed NCT00152503 - Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam Phase 2
Terminated NCT01891890 - Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) Phase 3

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