Trial Outcomes & Findings for Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures (NCT NCT00419393)
NCT ID: NCT00419393
Last Updated: 2014-09-05
Results Overview
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.
COMPLETED
PHASE3
190 participants
Duration of the Treatment Period (6 months-2 years)
2014-09-05
Participant Flow
The study began December 2007 recruiting in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
190
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Other: Sponsor request
|
3
|
|
Overall Study
Other: Subject had temporal lobectomy
|
1
|
|
Overall Study
Other: Site closure
|
1
|
|
Overall Study
Other: Other health problems
|
1
|
|
Overall Study
Other: Investigator decision
|
1
|
Baseline Characteristics
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Baseline characteristics by cohort
| Measure |
Keppra XR (Levetiracetam XR)
n=190 Participants
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
147 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
33.44 years
STANDARD_DEVIATION 14.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Keppra XR
n=189 Participants
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
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
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Keppra XR
n=189 Participants
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Keppra XR
n=189 Participants
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
|
5 number of subjects
|
SECONDARY outcome
Timeframe: Study entry through 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Keppra XR
n=139 Participants
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
|
77.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Study entry through 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Keppra XR
n=49 Participants
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
|
65.3 percentage of subjects
|
Adverse Events
Keppra XR (Levetiracetam XR)
Serious adverse events
| Measure |
Keppra XR (Levetiracetam XR)
n=189 participants at risk
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
General disorders
Chest pain
|
1.1%
2/189 • Number of events 2 • Up to two years
|
|
General disorders
Drowning
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
General disorders
Non-cardiac chest pain
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Cholangitis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Hepatitis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Infections and infestations
Pneumonia
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Injury, poisoning and procedural complications
Anticonvulsant toxicity
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Injury, poisoning and procedural complications
Lumbar puncture headache
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Nervous system disorders
Convulsion
|
2.1%
4/189 • Number of events 4 • Up to two years
|
|
Nervous system disorders
Aphasia
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Nervous system disorders
Grand mal convulsion
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Nervous system disorders
Postictal paralysis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with contraceptive device
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Psychiatric disorders
Psychotic disorder
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Renal and urinary disorders
Anuria
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.53%
1/189 • Number of events 1 • Up to two years
|
|
Surgical and medical procedures
Abortion induced
|
0.53%
1/189 • Number of events 1 • Up to two years
|
Other adverse events
| Measure |
Keppra XR (Levetiracetam XR)
n=189 participants at risk
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.9%
15/189 • Number of events 19 • Up to two years
|
|
Infections and infestations
Influenza
|
7.4%
14/189 • Number of events 27 • Up to two years
|
|
Nervous system disorders
Headache
|
13.8%
26/189 • Number of events 57 • Up to two years
|
|
Nervous system disorders
Somnolence
|
7.9%
15/189 • Number of events 18 • Up to two years
|
|
Nervous system disorders
Dizziness
|
5.3%
10/189 • Number of events 12 • Up to two years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
10/189 • Number of events 19 • Up to two years
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER