Trial record 1 of 1 for:
NCT00368069
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00368069 |
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Recruitment Status :
Completed
First Posted : August 24, 2006
Results First Posted : July 28, 2009
Last Update Posted : July 15, 2020
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Brief Summary:
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Keppra® extended release formulation - XR Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 158 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures. |
| Study Start Date : | August 2006 |
| Actual Primary Completion Date : | May 2007 |
| Actual Study Completion Date : | May 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
| Arm | Intervention/treatment |
|---|---|
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Experimental: Keppra® XR
Keppra® extended release formulation -XR
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Drug: Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily
Other Name: Levetiracetam XR |
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Placebo Comparator: Placebo
placebo
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Drug: Placebo
oral tablets, 2 tablets once daily |
Primary Outcome Measures :
- Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population [ Time Frame: Treatment period (12 weeks) ]Number of POS over the treatment period standardized to 1 week period.
- Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population [ Time Frame: Treatment Period (12 weeks) ]Number of POS over the treatment period standardized to 1 week period
Secondary Outcome Measures :
- POS Seizure Frequency Per Week Over Baseline and Treatment Period [ Time Frame: Baseline Period (8 weeks) - Treatment Period (12 weeks) ]
- All (Type I+II+III) Seizures Frequency Per Week [ Time Frame: Treatment period (12 weeks) ]Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)
- 50% Response in Weekly POS Frequency [ Time Frame: Treatment period (12 weeks) ]A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.
- Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks [ Time Frame: over the treatment period (12 weeks) ]The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a confirmed diagnosis of refractory epilepsy
- Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
- Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion Criteria:
- Seizures occurring in clusters
- Status epilepticus within 3 months of Visit 1
- History of non-epileptic seizures
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368069
Locations
Show 34 study locations
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00368069 |
| Other Study ID Numbers: |
N01235 2006-000987-10 ( EudraCT Number ) |
| First Posted: | August 24, 2006 Key Record Dates |
| Results First Posted: | July 28, 2009 |
| Last Update Posted: | July 15, 2020 |
| Last Verified: | June 2020 |
Keywords provided by UCB Pharma:
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Epilepsy Keppra® XR Levetiracetam XR Extended release |
Additional relevant MeSH terms:
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Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Levetiracetam Anticonvulsants Nootropic Agents |