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Trial record 35 of 235 for:    LEVETIRACETAM

A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset 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: NCT00367432
Recruitment Status : Completed
First Posted : August 22, 2006
Results First Posted : January 16, 2012
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsies
Partial
Intervention Drug: Levetiracetam
Enrollment 398
Recruitment Details The Full Analysis Set (FAS) includes all subjects to whom the investigational products are assigned after registration, excluding those with serious Good Clinical Practice violations , subjects not administered the investigational products and subjects for whom no data is available after assignment of the investigational products.
Pre-assignment Details

Eligible subjects from preceding study N01221 [NCT00280696] entered the First Period of this study and those subjects from N01221 [NCT00280696] who completed the First Period and subjects from the study N01020 [NCT00160615] entered the Second Period.

Participant Flow and Baseline Characteristics refer to the FAS.

Arm/Group Title Levetiracetam N01221 [NCT00280696] Levetiracetam N01020 [NCT00160615]
Hide Arm/Group Description N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam. N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
Period Title: First Period (16 Weeks)
Started 313 [1] 0
Completed 275 0
Not Completed 38 0
Reason Not Completed
Adverse Event             6             0
Lack of Efficacy             24             0
Withdrawal by Subject             6             0
Other Reason             2             0
[1]
Eligible subjects from preceding study N01221 [NCT00280696] entered the First Period of N01222
Period Title: Second Period (up to 54 Months)
Started 275 [1] 85 [2]
Completed 188 69
Not Completed 87 16
Reason Not Completed
Adverse Event             14             3
Lack of Efficacy             59             5
Lost to Follow-up             0             1
Withdrawal by Subject             8             5
Other Reason             6             2
[1]
275 subjects from N01221 [NCT00280696] completed First Period and entered Second Period of N01222
[2]
85 subjects from N01020 [NCT00160615] entered Second Period of N01222
Arm/Group Title Levetiracetam
Hide Arm/Group Description Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Baseline Participants 398
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 398 participants
33.68  (11.18)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 16 and 65 years Number Analyzed 398 participants
398
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 398 participants
Female
196
  49.2%
Male
202
  50.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants
Japanese 396
Asian (other than Japanese) 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 398 participants
398
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 398 participants
60.39  (13.64)
1.Primary Outcome
Title Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)
Hide Description

An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.

Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.

Time Frame During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set includes all subjects from N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 398
Measure Type: Number
Unit of Measure: participants
381
2.Secondary Outcome
Title Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
Hide Description

The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:

[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.

Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 313
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction
22.00
(-11.00 to 46.71)
3.Secondary Outcome
Title Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
Hide Description Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 313
Median (Inter-Quartile Range)
Unit of Measure: Seizures Per Week
2.13
(1.06 to 5.23)
4.Secondary Outcome
Title Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
Hide Description

The percent reduction from Baseline was computed as:

[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.

Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 313
Measure Type: Number
Unit of Measure: Participants
Responders 74
Non-responders 239
5.Secondary Outcome
Title Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Hide Description

Change in simple partial seizure frequency is given as a percent reduction computed as:

[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.

Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 173
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction
39.84
(-17.19 to 94.96)
6.Secondary Outcome
Title Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Hide Description

Change in complex partial seizure frequency is given as a percent reduction computed as:

[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.

Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 285
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction
20.59
(-15.24 to 52.94)
7.Secondary Outcome
Title Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
Hide Description

Change in secondary generalized seizure frequency is given as a percent reduction computed as:

[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.

Positive values in reduction means the value decreased from Baseline during the first 16-week Period.

Secondary generalized seizures belong to one of the 3 groups:

  • Simple partial sz evolving to gen sz
  • Complex partial sz evolving to gen sz
  • Simple partial sz evolving to Complex partial sz evolving to gen sz
Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 87
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction
76.56
(23.11 to 100.00)
8.Secondary Outcome
Title Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Hide Description

Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):

[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.

Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 308
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction
20.71
(-13.17 to 47.42)
9.Secondary Outcome
Title Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
Hide Description

Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):

[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.

Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.

Other types of Seizures are all seizures except Partial Seizures (Type 1).

Time Frame Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Overall Number of Participants Analyzed 5
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction
66.47
(7.48 to 100.00)
Time Frame Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Event Reporting Description Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   64/398 (16.08%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/398 (0.25%)  1
Cardiac disorders   
Palpitations * 1  1/398 (0.25%)  1
Eye disorders   
Eyelid Ptosis * 1  1/398 (0.25%)  1
Gastrointestinal disorders   
Enterocolitis * 1  1/398 (0.25%)  1
Ileus * 1  1/398 (0.25%)  1
Intestinal Obstruction * 1  1/398 (0.25%)  1
Irritable Bowel Syndrome * 1  1/398 (0.25%)  1
Rectal Ulcer Haemorrhage * 1  1/398 (0.25%)  1
Colonic Polyp * 1  1/398 (0.25%)  1
General disorders   
Pain * 1  1/398 (0.25%)  1
Pyrexia * 1  2/398 (0.50%)  2
Sudden Unexplained Death in Epilepsy * 1  1/398 (0.25%)  1
Immune system disorders   
Drug Hypersensitivity * 1  1/398 (0.25%)  1
Infections and infestations   
Acute Sinusitis * 1  1/398 (0.25%)  1
Cellulitis * 1  1/398 (0.25%)  1
Gastroenteritis Escherichia Coli * 1  1/398 (0.25%)  1
Infected Epidermal Cyst * 1  1/398 (0.25%)  1
Injection Site Infection * 1  1/398 (0.25%)  1
Lobar Pneumonia * 1  1/398 (0.25%)  1
Pneumonia * 1  4/398 (1.01%)  4
Pneumonia Mycoplasmal * 1  1/398 (0.25%)  1
Pyelonephritis * 1  1/398 (0.25%)  1
Respiratory Tract Infection * 1  1/398 (0.25%)  1
Sepsis * 1  1/398 (0.25%)  1
Injury, poisoning and procedural complications   
Anticonvulsant Toxicity * 1  3/398 (0.75%)  3
Burns Second Degree * 1  1/398 (0.25%)  1
Cervical Vertebral Fracture * 1  1/398 (0.25%)  1
Femoral Neck Fracture * 1  1/398 (0.25%)  1
Head Injury * 1  1/398 (0.25%)  1
Lumbar Vertebral Fracture * 1  1/398 (0.25%)  1
Patella Fracture * 1  1/398 (0.25%)  1
Rib Fracture * 1  1/398 (0.25%)  1
Road Traffic Accident * 1  1/398 (0.25%)  1
Skin Laceration * 1  3/398 (0.75%)  3
Skull Fracture * 1  1/398 (0.25%)  1
Subdural Haematoma * 1  1/398 (0.25%)  1
Investigations   
Anticonvulsant Drug Level Increased * 1  2/398 (0.50%)  2
Electrocardiogram ST Segment Elevation * 1  1/398 (0.25%)  1
Musculoskeletal and connective tissue disorders   
Haemarthrosis * 1  1/398 (0.25%)  1
Jaw Disorder * 1  1/398 (0.25%)  1
Spinal Column Stenosis * 1  1/398 (0.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Meningioma * 1  1/398 (0.25%)  1
Small Intestine Carcinoma * 1  1/398 (0.25%)  1
Nervous system disorders   
Cerebral Infarction * 1  1/398 (0.25%)  1
Complex Partial Seizures * 1  1/398 (0.25%)  1
Convulsion * 1  1/398 (0.25%)  1
Dizziness * 1  1/398 (0.25%)  1
Drug Withdrawal Convulsions * 1  1/398 (0.25%)  1
Epilepsy * 1  5/398 (1.26%)  5
Head Titubation * 1  1/398 (0.25%)  1
Neuropathy Peripheral * 1  1/398 (0.25%)  1
Postictal State * 1  1/398 (0.25%)  1
Status Epilepticus * 1  5/398 (1.26%)  9
Pregnancy, puerperium and perinatal conditions   
Abortion Complete * 1  1/398 (0.25%)  1
Psychiatric disorders   
Acute Psychosis * 1  1/398 (0.25%)  1
Depression * 1  1/398 (0.25%)  1
Hallucination * 1  1/398 (0.25%)  1
Ideas of Reference * 1  1/398 (0.25%)  1
Mental Disorder * 1  1/398 (0.25%)  1
Morose * 1  1/398 (0.25%)  3
Suicide Attempt * 1  1/398 (0.25%)  1
Renal and urinary disorders   
Urethral Stenosis * 1  1/398 (0.25%)  2
Reproductive system and breast disorders   
Lactation Disorder * 1  1/398 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis * 1  1/398 (0.25%)  1
Choking * 1  1/398 (0.25%)  1
Pneumonia Aspiration * 1  1/398 (0.25%)  1
Surgical and medical procedures   
Abortion Induced * 1  2/398 (0.50%)  2
Brain Operation * 1  1/398 (0.25%)  1
Medical Diet * 1  1/398 (0.25%)  1
Wisdom Teeth Removal * 1  1/398 (0.25%)  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%
Levetiracetam
Affected / at Risk (%) # Events
Total   369/398 (92.71%)    
Gastrointestinal disorders   
Abdominal Pain * 1  38/398 (9.55%)  67
Abdominal Pain Upper * 1  20/398 (5.03%)  40
Constipation * 1  45/398 (11.31%)  70
Diarrhoea * 1  69/398 (17.34%)  128
Nausea * 1  44/398 (11.06%)  53
Stomatitis * 1  42/398 (10.55%)  75
Toothache * 1  21/398 (5.28%)  32
Vomiting * 1  40/398 (10.05%)  85
General disorders   
Pyrexia * 1  52/398 (13.07%)  95
Immune system disorders   
Seasonal Allergy * 1  29/398 (7.29%)  43
Infections and infestations   
Dental Caries * 1  42/398 (10.55%)  49
Gastroenteritis * 1  27/398 (6.78%)  34
Influenza * 1  32/398 (8.04%)  32
Nasopharyngitis * 1  308/398 (77.39%)  1360
Pharyngitis * 1  25/398 (6.28%)  38
Rhinitis * 1  22/398 (5.53%)  26
Injury, poisoning and procedural complications   
Contusion * 1  110/398 (27.64%)  237
Excoriation * 1  52/398 (13.07%)  85
Injury * 1  33/398 (8.29%)  39
Joint Sprain * 1  27/398 (6.78%)  37
Laceration * 1  20/398 (5.03%)  23
Skin Laceration * 1  31/398 (7.79%)  53
Thermal Burn * 1  36/398 (9.05%)  43
Investigations   
Weight Decreased * 1  28/398 (7.04%)  33
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  31/398 (7.79%)  34
Back Pain * 1  45/398 (11.31%)  70
Myalgia * 1  21/398 (5.28%)  27
Nervous system disorders   
Dizziness * 1  63/398 (15.83%)  92
Epilepsy * 1  31/398 (7.79%)  37
Headache * 1  96/398 (24.12%)  261
Somnolence * 1  159/398 (39.95%)  226
Psychiatric disorders   
Insomnia * 1  24/398 (6.03%)  26
Respiratory, thoracic and mediastinal disorders   
Cough * 1  21/398 (5.28%)  25
Pharyngolaryngeal Pain * 1  32/398 (8.04%)  60
Rhinitis Allergic * 1  20/398 (5.03%)  26
Upper Respiratory Tract Inflammation * 1  33/398 (8.29%)  46
Skin and subcutaneous tissue disorders   
Eczema * 1  47/398 (11.81%)  61
Pruritus * 1  21/398 (5.28%)  25
Rash * 1  26/398 (6.53%)  37
*
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT00367432     History of Changes
Other Study ID Numbers: N01222
2014-004334-26 ( EudraCT Number )
First Submitted: August 21, 2006
First Posted: August 22, 2006
Results First Submitted: December 2, 2011
Results First Posted: January 16, 2012
Last Update Posted: April 21, 2015