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Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291655
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : November 13, 2009
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Levetiracetam
Enrollment 130
Recruitment Details Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.
Pre-assignment Details  
Arm/Group Title Levetiracetam Open- Label Treatment
Hide Arm/Group Description Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Period Title: Overall Study
Started 130
Completed 115
Not Completed 15
Arm/Group Title Levetiracetam Open- Label Treatment
Hide Arm/Group Description Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Number of Baseline Participants 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants
40.68  (18.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants
Female
58
  44.6%
Male
72
  55.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants
France 18
Finland 9
Poland 32
Belgium 25
Bulgaria 31
Switzerland 15
1.Primary Outcome
Title Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Hide Description Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
Time Frame during open-label therapy phase of 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population that includes all subjects that have been treated once.
Arm/Group Title Levetiracetam Open- Label Treatment
Hide Arm/Group Description:
Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: participants
Subjects with at least one AE 40
Subjects with AEs leading to dose change 8
Subjects with AEs leading to trial discontinuation 1
Subjects with drug-related AEs 16
Subjects with AEs of severe intensity 4
Subjects with serious AEs 6
Subjects with study drug-related serious AEs 0
Number of deaths 0
2.Secondary Outcome
Title Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Hide Description [Not Specified]
Time Frame Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a discontinuation visit
Arm/Group Title Levetiracetam Open- Label Treatment
Hide Arm/Group Description:
Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: kg
0.71  (3.16)
Time Frame Open-label treatment over 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam Open- Label Treatment
Hide Arm/Group Description Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
All-Cause Mortality
Levetiracetam Open- Label Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam Open- Label Treatment
Affected / at Risk (%) # Events
Total   6/130 (4.62%)    
Cardiac disorders   
Acute coronary syndrome * 1  1/130 (0.77%)  1
Hepatobiliary disorders   
Hepatic cirrhosis * 1  1/130 (0.77%)  1
Infections and infestations   
Tonsillitis * 1  1/130 (0.77%)  1
Injury, poisoning and procedural complications   
Skin laceration * 1  1/130 (0.77%)  1
Foot fracture * 1  1/130 (0.77%)  1
Nervous system disorders   
Grand mal convulsion * 1  1/130 (0.77%)  1
Psychiatric disorders   
Alcoholism * 1  1/130 (0.77%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, medDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Levetiracetam Open- Label Treatment
Affected / at Risk (%) # Events
Total   10/130 (7.69%)    
Investigations   
Weight decreased * 1  3/130 (2.31%)  3
Weight increased * 1  7/130 (5.38%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical trial call center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00291655     History of Changes
Other Study ID Numbers: N01237
EUDRACT NUMBER: 2006-000173-29
First Submitted: February 10, 2006
First Posted: February 14, 2006
Results First Submitted: August 25, 2009
Results First Posted: November 13, 2009
Last Update Posted: May 18, 2015