Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

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: NCT00419393
Recruitment Status : Completed
First Posted : January 8, 2007
Results First Posted : July 13, 2011
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Keppra XR (Levetiracetam XR)
Enrollment 190
Recruitment Details The study began December 2007 recruiting in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.
Pre-assignment Details  
Arm/Group Title Keppra XR (Levetiracetam XR)
Hide Arm/Group Description 1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Period Title: Overall Study
Started 190 [1]
Completed 166
Not Completed 24
Reason Not Completed
Adverse Event             5
Protocol Violation             5
Withdrawal by Subject             7
Other: Sponsor request             3
Other: Subject had temporal lobectomy             1
Other: Site closure             1
Other: Other health problems             1
Other: Investigator decision             1
[1]
One subject did not receive medication
Arm/Group Title Keppra XR (Levetiracetam XR)
Hide Arm/Group Description 1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
<=18 years
40
  21.1%
Between 18 and 65 years
147
  77.4%
>=65 years
3
   1.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants
33.44  (14.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
111
  58.4%
Male
79
  41.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants
United States 26
Mexico 49
Poland 59
Russian Federation 56
1.Primary Outcome
Title Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Hide Description An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time Frame Duration of the Treatment Period (6 months-2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.
Arm/Group Title Keppra XR
Hide Arm/Group Description:
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: number of subjects
126
2.Primary Outcome
Title Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Hide Description A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Time Frame Duration of the Treatment Period (6 months-2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.
Arm/Group Title Keppra XR
Hide Arm/Group Description:
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: number of subjects
22
3.Primary Outcome
Title Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
Hide Description An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time Frame Duration of the Treatment Period (6 months-2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.
Arm/Group Title Keppra XR
Hide Arm/Group Description:
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: number of subjects
5
4.Secondary Outcome
Title Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Hide Description Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
Time Frame Study entry through 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 190 subjects beginning the study, 139 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 6 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.
Arm/Group Title Keppra XR
Hide Arm/Group Description:
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Overall Number of Participants Analyzed 139
Measure Type: Number
Unit of Measure: percentage of subjects
77.0
5.Secondary Outcome
Title Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Hide Description Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.
Time Frame Study entry through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 190 subjects beginning the study, 49 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 12 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.
Arm/Group Title Keppra XR
Hide Arm/Group Description:
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of subjects
65.3
Time Frame Up to two years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Keppra XR (Levetiracetam XR)
Hide Arm/Group Description 1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
All-Cause Mortality
Keppra XR (Levetiracetam XR)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Keppra XR (Levetiracetam XR)
Affected / at Risk (%) # Events
Total   22/189 (11.64%)    
Cardiac disorders   
Angina pectoris * 1  1/189 (0.53%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/189 (0.53%)  1
General disorders   
Chest pain * 1  2/189 (1.06%)  2
Drowning * 1  1/189 (0.53%)  1
Non-cardiac chest pain * 1  1/189 (0.53%)  1
Hepatobiliary disorders   
Bile duct stone * 1  1/189 (0.53%)  1
Cholangitis * 1  1/189 (0.53%)  1
Cholecystitis * 1  1/189 (0.53%)  1
Hepatic cirrhosis * 1  1/189 (0.53%)  1
Hepatic fibrosis * 1  1/189 (0.53%)  1
Hepatitis * 1  1/189 (0.53%)  1
Infections and infestations   
Pneumonia * 1  1/189 (0.53%)  1
Pulmonary tuberculosis * 1  1/189 (0.53%)  1
Injury, poisoning and procedural complications   
Anticonvulsant toxicity * 1  1/189 (0.53%)  1
Concussion * 1  1/189 (0.53%)  1
Lumbar puncture headache * 1  1/189 (0.53%)  1
Spinal compression fracture * 1  1/189 (0.53%)  1
Musculoskeletal and connective tissue disorders   
Periostitis * 1  1/189 (0.53%)  1
Nervous system disorders   
Convulsion * 1  4/189 (2.12%)  4
Aphasia * 1  1/189 (0.53%)  1
Grand mal convulsion * 1  1/189 (0.53%)  1
Postictal paralysis * 1  1/189 (0.53%)  1
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  1/189 (0.53%)  1
Pregnancy with contraceptive device * 1  1/189 (0.53%)  1
Psychiatric disorders   
Psychotic disorder * 1  1/189 (0.53%)  1
Renal and urinary disorders   
Anuria * 1  1/189 (0.53%)  1
Hydronephrosis * 1  1/189 (0.53%)  1
Nephrolithiasis * 1  1/189 (0.53%)  1
Reproductive system and breast disorders   
Metrorrhagia * 1  1/189 (0.53%)  1
Skin and subcutaneous tissue disorders   
Toxic skin eruption * 1  1/189 (0.53%)  1
Surgical and medical procedures   
Abortion induced * 1  1/189 (0.53%)  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 5%
Keppra XR (Levetiracetam XR)
Affected / at Risk (%) # Events
Total   57/189 (30.16%)    
Infections and infestations   
Nasopharyngitis * 1  15/189 (7.94%)  19
Influenza * 1  14/189 (7.41%)  27
Nervous system disorders   
Headache * 1  26/189 (13.76%)  57
Somnolence * 1  15/189 (7.94%)  18
Dizziness * 1  10/189 (5.29%)  12
Respiratory, thoracic and mediastinal disorders   
Cough * 1  10/189 (5.29%)  19
*
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 but <= 180 days to review results communications prior to public release and may delete information that is confidential and 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 the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00419393     History of Changes
Other Study ID Numbers: N01281
2007-000899-17 ( EudraCT Number )
First Submitted: January 4, 2007
First Posted: January 8, 2007
Results First Submitted: March 25, 2011
Results First Posted: July 13, 2011
Last Update Posted: September 5, 2014