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Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

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ClinicalTrials.gov Identifier: NCT00150813
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : October 1, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy, Tonic-clonic
Intervention Drug: Levetiracetam
Enrollment 66
Recruitment Details The study started to enroll patients in August 2005 and concluded in May 2007.
Pre-assignment Details Participant Flow refers to the Intention-to-Treat (ITT) Set.
Arm/Group Title Levetiracetam
Hide Arm/Group Description Subjects received open-label Levetiracetam.
Period Title: Overall Study
Started 66
Completed 48
Not Completed 18
Reason Not Completed
Adverse Event             1
Lack of Efficacy             1
Lost to Follow-up             5
Withdrawal by Subject             5
Remission             3
Planned pregancy             1
Switch to commercially available LEV             2
Arm/Group Title Levetiracetam
Hide Arm/Group Description Subjects received open-label Levetiracetam.
Overall Number of Baseline Participants 66
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
<=18 years
0
   0.0%
Between 18 and 65 years
56
  84.8%
>=65 years
10
  15.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants
41.39  (18.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
Female
31
  47.0%
Male
35
  53.0%
1.Primary Outcome
Title Percentage Participants With Treatment Emergent Adverse Events
Hide Description An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Subjects received open-label Levetiracetam.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of participants
27.3
Time Frame Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 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   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%)
Total   4/66 (6.06%) 
Nervous system disorders   
Encephalopathy * 1  1/66 (1.52%) 
Polyneuropathy * 1  1/66 (1.52%) 
Epilepsy * 1  1/66 (1.52%) 
Completed suicide * 1  1/66 (1.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam
Affected / at Risk (%)
Total   0/66 (0.00%) 
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 ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00150813     History of Changes
Other Study ID Numbers: N01127
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: February 8, 2018
Results First Posted: October 1, 2018
Last Update Posted: November 21, 2018