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Trial record 1 of 1 for:    NCT00160654
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Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

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ClinicalTrials.gov Identifier: NCT00160654
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy, Partial
Intervention Drug: Levetiracetam
Enrollment 251
Recruitment Details The study started to enroll patients in November 2003 and concluded in May 2006.
Pre-assignment Details Participant Flow refers to the Intend-to-treat (ITT) Set.
Arm/Group Title Levetiracetam
Hide Arm/Group Description Subjects received open-label Levetiracetam.
Period Title: Overall Study
Started 251
Completed 218
Not Completed 33
Reason Not Completed
Adverse Event             14
Lack of Efficacy             4
Lost to Follow-up             2
Intake of expired drug             7
Psychological trauma             1
Sponsor decision             1
Patient met exclusion criteria             1
Patient decision             1
Poor compliance, dilantin toxicity             1
Met exclusion criteria             1
Arm/Group Title Levetiracetam
Hide Arm/Group Description Subjects received open-label Levetiracetam.
Overall Number of Baseline Participants 251
Hide Baseline Analysis Population Description
Baseline characteristics refer to the Intend-to-treat (ITT) Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
<=18 years
10
   4.0%
Between 18 and 65 years
240
  95.6%
>=65 years
1
   0.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 251 participants
34.42  (11.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
Female
137
  54.6%
Male
114
  45.4%
1.Primary Outcome
Title Number of Patients With Adverse Events (AEs)
Hide Description 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.
Time Frame From Baseline until Safety visit (two weeks after last dose; up to Week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 251
Measure Type: Number
Unit of Measure: Participants
184
2.Secondary Outcome
Title Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period
Hide Description

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.

Time Frame Week 16, compared to Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 237
Median (Inter-Quartile Range)
Unit of Measure: percentage changes
-48.34
(-89.96 to 6.19)
3.Secondary Outcome
Title Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period
Hide Description

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.

Time Frame Week 16, compared to Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 243
Median (Inter-Quartile Range)
Unit of Measure: percentage changes
-46.43
(-89.29 to 5.88)
4.Secondary Outcome
Title Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16
Hide Description

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.

Time Frame Week 16, compared to Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 243
Measure Type: Number
Unit of Measure: percentage of participants
Partial (Type I) seizures 47.7
Total (type I+II+III) seizures 48.1
5.Secondary Outcome
Title Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16
Hide Description

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.

Time Frame Week 16, compared to Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 243
Measure Type: Number
Unit of Measure: percentage of participants
Partial (Type I) seizures 20.2
Total (type I+II+III) seizures 20.2
6.Secondary Outcome
Title Percentage of Patients With Categorized Change From Baseline in Severity of Illness
Hide Description 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.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 251
Measure Type: Number
Unit of Measure: percentage of participants
Marked improvement 34.1
Moderate improvement 25.3
Slight improvement 16.5
No change 17.7
Slight worsening 3.2
Moderate worsening 2.8
Marked worsening 0.4
7.Secondary Outcome
Title Retention Rate at Week 16
Hide Description 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.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 251
Measure Type: Number
Unit of Measure: percentage of participants
85.3
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description Subjects received open-label Levetiracetam.
All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%)
Total   15/251 (5.98%) 
Blood and lymphatic system disorders   
Bicytopenia * 1  1/251 (0.40%) 
General disorders   
Adverse drug reaction * 1  1/251 (0.40%) 
Infections and infestations   
Dengue fever * 1  1/251 (0.40%) 
Injury, poisoning and procedural complications   
Thermal burn * 1  1/251 (0.40%) 
Nervous system disorders   
Convulsion * 1  4/251 (1.59%) 
Coordination abnormal * 1  1/251 (0.40%) 
Depressed level of consciousness * 1  1/251 (0.40%) 
Dizziness * 1  2/251 (0.80%) 
Grand mal convulsion * 1  2/251 (0.80%) 
Lethargy * 1  1/251 (0.40%) 
Somnolence * 1  1/251 (0.40%) 
Psychiatric disorders   
Aggression * 1  1/251 (0.40%) 
Anger * 1  1/251 (0.40%) 
Hallucination, auditory * 1  1/251 (0.40%) 
Suicide attempt * 1  1/251 (0.40%) 
Skin and subcutaneous tissue disorders   
Rash * 1  1/251 (0.40%) 
Rash maculo-papular * 1  1/251 (0.40%) 
Stevens-Johnson syndrome * 1  1/251 (0.40%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam
Affected / at Risk (%)
Total   136/251 (54.18%) 
Gastrointestinal disorders   
Nausea * 1  14/251 (5.58%) 
General disorders   
Fatigue * 1  15/251 (5.98%) 
Nervous system disorders   
Dizziness * 1  36/251 (14.34%) 
Headache * 1  16/251 (6.37%) 
Sedation * 1  15/251 (5.98%) 
Somnolence * 1  75/251 (29.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00160654    
Other Study ID Numbers: N01036
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: February 8, 2018
Results First Posted: August 19, 2020
Last Update Posted: August 19, 2020