NCT00160654

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

Completed Phase 4 Results posted Last updated 19 August 2020

What this trial tests

Phase 4 trial testing Levetiracetam in Epilepsy, Partial in 251 participants. Completed in 12 December 2006.

Timeline

24 November 2003

Primary endpoint
12 December 2006

12 December 2006

Quick facts

Lead sponsor	UCB Pharma
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	251
Start date	24 November 2003
Primary completion	12 December 2006
Estimated completion	12 December 2006
Sites	29 locations across Hong Kong, Malaysia, Taiwan, Philippines, Thailand, Singapore

Drugs / interventions tested

• Levetiracetam (levetiracetam) — full drug profile →

Conditions studied

• Epilepsy, Partial — all drugs for Epilepsy, Partial →

Sponsor

UCB Pharma — full company profile →

Who can join

18 and older, any sex, with Epilepsy, Partial. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Adverse Events (AEs) Primary · 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.

Group	Value	95% CI
Levetiracetam	184

Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period Secondary · 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.

Group	Value	95% CI
Levetiracetam	-48.34	-89.96 – 6.19

Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period Secondary · 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) s

Group	Value	95% CI
Levetiracetam	-46.43	-89.29 – 5.88

Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 Secondary · 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.

Partial (Type I) seizures

Group	Value	95% CI
Levetiracetam	47.7

Total (type I+II+III) seizures

Group	Value	95% CI
Levetiracetam	48.1

Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 Secondary · 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.

Partial (Type I) seizures

Group	Value	95% CI
Levetiracetam	20.2

Total (type I+II+III) seizures

Group	Value	95% CI
Levetiracetam	20.2

Percentage of Patients With Categorized Change From Baseline in Severity of Illness Secondary · 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.

Marked improvement

Group	Value	95% CI
Levetiracetam	34.1

Moderate improvement

Group	Value	95% CI
Levetiracetam	25.3

Slight improvement

Group	Value	95% CI
Levetiracetam	16.5

No change

Group	Value	95% CI
Levetiracetam	17.7

Slight worsening

Group	Value	95% CI
Levetiracetam	3.2

Moderate worsening

Group	Value	95% CI
Levetiracetam	2.8

Marked worsening

Group	Value	95% CI
Levetiracetam	0.4

Retention Rate at Week 16 Secondary · 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.

Group	Value	95% CI
Levetiracetam	85.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Levetiracetam

Serious: 15/251 (6%)

Deaths: —

Serious adverse events (18 terms)

Reaction	System	Levetiracetam
Convulsion	Nervous system disorders	—
Dizziness	Nervous system disorders	—
Grand mal convulsion	Nervous system disorders	—
Bicytopenia	Blood and lymphatic system disorders	—
Adverse drug reaction	General disorders	—
Dengue fever	Infections and infestations	—
Thermal burn	Injury, poisoning and procedural complications	—
Coordination abnormal	Nervous system disorders	—
Depressed level of consciousness	Nervous system disorders	—
Lethargy	Nervous system disorders	—
Somnolence	Nervous system disorders	—
Aggression	Psychiatric disorders	—
Anger	Psychiatric disorders	—
Hallucination, auditory	Psychiatric disorders	—
Suicide attempt	Psychiatric disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Levetiracetam
Somnolence	Nervous system disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Fatigue	General disorders	—
Sedation	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—

Most-reported serious reactions: Convulsion, Dizziness, Grand mal convulsion, Bicytopenia, Adverse drug reaction, Dengue fever, Thermal burn, Coordination abnormal.

Data from ClinicalTrials.gov NCT00160654 adverse events section.

Sponsor's own description

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

The optimal dose in daily clinical practice will be used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.