Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
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| ClinicalTrials.gov Identifier: NCT00160654 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
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Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.
The optimal dose in daily clinical practice will be used.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy, Partial | Drug: Levetiracetam | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 251 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IV, Open-label, Multi-center, Community-based Trial in Asia Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy. |
| Actual Study Start Date : | November 24, 2003 |
| Actual Primary Completion Date : | December 12, 2006 |
| Actual Study Completion Date : | December 12, 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Levetiracetam
Subjects received open-label Levetiracetam.
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Drug: Levetiracetam
Other Name: Keppra |
- Number of Patients With Adverse Events (AEs) [ Time Frame: From Baseline until Safety visit (two weeks after last dose; up to Week 18) ]An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
- Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period [ Time Frame: Week 16, compared to Baseline ]
Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period.
Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.
A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline.
- Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period [ Time Frame: Week 16, compared to Baseline ]
Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period.
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.
A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline.
- Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 [ Time Frame: Week 16, compared to Baseline ]
50% response in seizure frequency per Week is defined as >=50% reduction in seizure frequency from Baseline.
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.
- Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 [ Time Frame: Week 16, compared to Baseline ]
100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline.
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.
- Percentage of Patients With Categorized Change From Baseline in Severity of Illness [ Time Frame: Baseline, Week 16 ]The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening.
- Retention Rate at Week 16 [ Time Frame: Week 16 ]Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
- Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
- Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.
Exclusion Criteria:
- Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
- Presence of known pseudoseizures within the last year.
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
- Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
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): NCT00160654
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| Study Director: | UCB Cares | UCB (+1 844 599 2273) |
Publications of Results:
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00160654 |
| Other Study ID Numbers: |
N01036 |
| First Posted: | September 12, 2005 Key Record Dates |
| Results First Posted: | August 19, 2020 |
| Last Update Posted: | August 19, 2020 |
| Last Verified: | August 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Epilepsy Partial Onset Seizures Keppra Levetiracetam |
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Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Levetiracetam Anticonvulsants Nootropic Agents |