Epilepsy
Conditions
Keywords
Keppra XR, Levetiracetam XR, long term, partial seizures
Brief summary
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
Interventions
DRUGKeppra XR (Levetiracetam XR)
500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who were randomized into study N01280 \[NCT00419094\], and completed the 2 week up titration period
Exclusion criteria
* Subjects who did not meet the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | Duration of the Treatment Period (6 months-2 years) | 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. |
| Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | Duration of the Treatment Period (6 months-2 years) | 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. |
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period | Duration of the Treatment Period (6 months-2 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months | Study entry through 6 months | 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. |
| Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months | Study entry through 12 months | 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. |
Countries
Mexico, Poland, Russia, United States
Participant flow
Recruitment details
The study began December 2007 recruiting in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.
Participants by arm
| Arm | Count |
|---|---|
| Keppra XR (Levetiracetam XR) 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) | 190 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Other: Investigator decision | 1 |
| Overall Study | Other: Other health problems | 1 |
| Overall Study | Other: Site closure | 1 |
| Overall Study | Other: Sponsor request | 3 |
| Overall Study | Other: Subject had temporal lobectomy | 1 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Keppra XR (Levetiracetam XR) |
|---|---|
| Age, Categorical <=18 years | 40 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 147 Participants |
| Age, Continuous | 33.44 years STANDARD_DEVIATION 14.46 |
| Region of Enrollment Mexico | 49 participants |
| Region of Enrollment Poland | 59 participants |
| Region of Enrollment Russian Federation | 56 participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 57 / 189 |
| serious Total, serious adverse events | 22 / 189 |
Outcome results
Primary
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Keppra XR | Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period | 5 number of subjects |
Primary
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Keppra XR | Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | 22 number of subjects |
Primary
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Keppra XR | Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | 126 number of subjects |
Secondary
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Keppra XR | Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months | 65.3 percentage of subjects |
Secondary
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Keppra XR | Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months | 77.0 percentage of subjects |