Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

Epilepsy, Partial Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160654
• Other study ID #: N01036
• Status: Completed
• Phase: Phase 4
• Start date: November 24, 2003
• Est. completion date: December 12, 2006

Study information

• Verified date: August 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: December 12, 2006
• Est. primary completion date: December 12, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Partial

Intervention

Drug:
• Levetiracetam
Pharmaceutical form: oral tablets Concentration: 500 mg Route of administration: Oral use

Locations

Country	Name	City	State
Hong Kong	N01036 808	Hong Kong
Hong Kong	N01036 842	Hong Kong
Hong Kong	N01036 815	Kwun Tong
Malaysia	N01036 811	Kuala Lumpur
Malaysia	N01036 812	Kuala Lumpur
Malaysia	N01036 813	Kuala Lumpur
Philippines	N01036 830	Manila
Philippines	N01036 831	Manila
Philippines	N01036 829	Quezon
Singapore	N01036 804	Singapore
Singapore	N01036 806	Singapore
Singapore	N01036 807	Singapore
Taiwan	N01036 828	Changhua
Taiwan	N01036 827	Hualien City
Taiwan	N01036 834	Kaohsiung
Taiwan	N01036 835	Kaohsiung
Taiwan	N01036 825	Kaohsiung City
Taiwan	N01036 817	Taichung
Taiwan	N01036 823	Taichung city
Taiwan	N01036 818	Tainan
Taiwan	N01036 819	Taipei
Taiwan	N01036 820	Taipei
Taiwan	N01036 821	Taipei
Taiwan	N01036 822	Taoyuan
Thailand	N01036 809	Bangkok
Thailand	N01036 840	Bangkok
Thailand	N01036 841	Bangkok
Thailand	N01036 839	Chiang Mai
Thailand	N01036 810	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Hong Kong,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand, 

References & Publications (1)

Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, Tonner F, Beh K, Edrich P; N01036 (SKATE II) Investigator Group. Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events (AEs)	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.	From Baseline until Safety visit (two weeks after last dose; up to Week 18)
Secondary	Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period	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.	Week 16, compared to Baseline
Secondary	Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period	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.	Week 16, compared to Baseline
Secondary	Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16	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.	Week 16, compared to Baseline
Secondary	Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16	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.	Week 16, compared to Baseline
Secondary	Percentage of Patients With Categorized Change From Baseline in Severity of Illness	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.	Baseline, Week 16
Secondary	Retention Rate at 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.	Week 16

External Links

•   Clinical Study Summary on UCB.com
•   FDA Safety Alerts and Recalls