Trial Outcomes & Findings for Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy (NCT NCT00160654)

Last Updated: 2020-08-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

251 participants

Primary outcome timeframe

From Baseline until Safety visit (two weeks after last dose; up to Week 18)

Results posted on

2020-08-19

Participant Flow

The study started to enroll patients in November 2003 and concluded in May 2006.

Participant Flow refers to the Intend-to-treat (ITT) Set.

Participant milestones

Participant milestones
Measure	Levetiracetam Subjects received open-label Levetiracetam.
Overall Study STARTED	251
Overall Study COMPLETED	218
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Levetiracetam Subjects received open-label Levetiracetam.
Overall Study Adverse Event	14
Overall Study Lack of Efficacy	4
Overall Study Lost to Follow-up	2
Overall Study Intake of expired drug	7
Overall Study Psychological trauma	1
Overall Study Sponsor decision	1
Overall Study Patient met exclusion criteria	1
Overall Study Patient decision	1
Overall Study Poor compliance, dilantin toxicity	1
Overall Study Met exclusion criteria	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam n=251 Participants Subjects received open-label Levetiracetam.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	240 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	34.42 years STANDARD_DEVIATION 11.21 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=251 Participants Subjects received open-label Levetiracetam.
Number of Patients With Adverse Events (AEs)	184 Participants

SECONDARY outcome

Timeframe: Week 16, compared to Baseline

Population: Only subjects with partial (Type I) seizure frequency per week at baseline \>= 0 and non-missing values on treatment period are included in the analysis. Subjects withdrawing from the study are included up to their early discontinuation visit.

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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=237 Participants Subjects received open-label Levetiracetam.
Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period	-48.34 percentage changes Interval -89.96 to 6.19

SECONDARY outcome

Timeframe: Week 16, compared to Baseline

Population: Only subjects with total (Type I+II+III) seizure frequency per week at baseline \>= 0 and non-missing values on treatment period are included in the analysis. Subjects withdrawing from the study are included up to their early discontinuation visit.

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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=243 Participants Subjects received open-label Levetiracetam.
Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period	-46.43 percentage changes Interval -89.29 to 5.88

SECONDARY outcome

Timeframe: Week 16, compared to Baseline

Population: Only subjects with seizure frequency per week at baseline \>= 0 and non-missing values on treatment period are taken into account for the responder rates. By convention, subjects with frequency per week at baseline equal to zero were considered as non-responder.

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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=243 Participants Subjects received open-label Levetiracetam.
Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 Partial (Type I) seizures	47.7 percentage of participants
Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 Total (type I+II+III) seizures	48.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=243 Participants Subjects received open-label Levetiracetam.
Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 Partial (Type I) seizures	20.2 percentage of participants
Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 Total (type I+II+III) seizures	20.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=251 Participants Subjects received open-label Levetiracetam.
Percentage of Patients With Categorized Change From Baseline in Severity of Illness Marked improvement	34.1 percentage of participants
Percentage of Patients With Categorized Change From Baseline in Severity of Illness Moderate improvement	25.3 percentage of participants
Percentage of Patients With Categorized Change From Baseline in Severity of Illness Slight improvement	16.5 percentage of participants
Percentage of Patients With Categorized Change From Baseline in Severity of Illness No change	17.7 percentage of participants
Percentage of Patients With Categorized Change From Baseline in Severity of Illness Slight worsening	3.2 percentage of participants
Percentage of Patients With Categorized Change From Baseline in Severity of Illness Moderate worsening	2.8 percentage of participants
Percentage of Patients With Categorized Change From Baseline in Severity of Illness Marked worsening	0.4 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Levetiracetam n=251 Participants Subjects received open-label Levetiracetam.
Retention Rate at Week 16	85.3 percentage of participants

Adverse Events

Levetiracetam

Serious events: 15 serious events

Other events: 136 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Levetiracetam n=251 participants at risk Subjects received open-label Levetiracetam.
Blood and lymphatic system disorders Bicytopenia	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
General disorders Adverse drug reaction	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Infections and infestations Dengue fever	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Injury, poisoning and procedural complications Thermal burn	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Convulsion	1.6% 4/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Coordination abnormal	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Depressed level of consciousness	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Dizziness	0.80% 2/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Grand mal convulsion	0.80% 2/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Lethargy	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Somnolence	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Psychiatric disorders Aggression	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Psychiatric disorders Anger	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Psychiatric disorders Hallucination, auditory	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Psychiatric disorders Suicide attempt	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Skin and subcutaneous tissue disorders Rash	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.40% 1/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).

Other adverse events

Other adverse events
Measure	Levetiracetam n=251 participants at risk Subjects received open-label Levetiracetam.
Gastrointestinal disorders Nausea	5.6% 14/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
General disorders Fatigue	6.0% 15/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Dizziness	14.3% 36/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Headache	6.4% 16/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Sedation	6.0% 15/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
Nervous system disorders Somnolence	29.9% 75/251 • Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60