Trial Outcomes & Findings for A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR (NCT NCT00368069)
NCT ID: NCT00368069
Last Updated: 2020-07-15
Results Overview
Number of POS over the treatment period standardized to 1 week period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Treatment period (12 weeks)
Results posted on
2020-07-15
Participant Flow
The N01235 study began recruitment in August 2006 with study completion occurring in May 2007.
Baseline and Participant Flow data consists of the Intent-to-Treat (ITT) analysis group. The ITT group consists of all randomized subjects.
Participant milestones
| Measure |
Keppra®
Keppra® extended release formulation (XR)
|
Placebo
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
71
|
72
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Keppra®
Keppra® extended release formulation (XR)
|
Placebo
placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal of Consent
|
2
|
1
|
|
Overall Study
no blood sampling possible
|
0
|
1
|
Baseline Characteristics
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Baseline characteristics by cohort
| Measure |
Keppra®
n=79 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=79 Participants
placebo
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.97 years
STANDARD_DEVIATION 13.41 • n=5 Participants
|
32.38 years
STANDARD_DEVIATION 12.60 • n=7 Participants
|
33.17 years
STANDARD_DEVIATION 13.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31.0 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4.0 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25.0 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8.0 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38.0 participants
n=5 Participants
|
|
Region of Enrollment
India
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51.0 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment period (12 weeks)Population: Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)
Number of POS over the treatment period standardized to 1 week period.
Outcome measures
| Measure |
Keppra®
n=75 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=78 Participants
placebo
|
|---|---|---|
|
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
|
0.912 seizures per week (log-transformed data)
Standard Error 0.053
|
1.067 seizures per week (log-transformed data)
Standard Error 0.052
|
PRIMARY outcome
Timeframe: Treatment Period (12 weeks)Population: Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)
Number of POS over the treatment period standardized to 1 week period
Outcome measures
| Measure |
Keppra®
n=67 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=69 Participants
placebo
|
|---|---|---|
|
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
|
0.914 seizures per week (log-transformed data)
Standard Error 0.049
|
1.119 seizures per week (log-transformed data)
Standard Error 0.048
|
SECONDARY outcome
Timeframe: Baseline Period (8 weeks) - Treatment Period (12 weeks)Population: ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for levetiracetam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures
Outcome measures
| Measure |
Keppra®
n=79 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=79 Participants
placebo
|
|---|---|---|
|
POS Seizure Frequency Per Week Over Baseline and Treatment Period
Baseline POS frequency per week
|
1.80 seizures per week
Interval 1.13 to 4.13
|
2.11 seizures per week
Interval 1.33 to 3.26
|
|
POS Seizure Frequency Per Week Over Baseline and Treatment Period
Treatment POS frequency per week
|
0.99 seizures per week
Interval 0.33 to 2.7
|
1.36 seizures per week
Interval 0.92 to 2.85
|
SECONDARY outcome
Timeframe: Treatment period (12 weeks)Population: ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)
Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)
Outcome measures
| Measure |
Keppra®
n=75 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=78 Participants
placebo
|
|---|---|---|
|
All (Type I+II+III) Seizures Frequency Per Week
|
0.928 seizures per week (log-transformed data)
Standard Error 0.053
|
1.086 seizures per week (log-transformed data)
Standard Error 0.052
|
SECONDARY outcome
Timeframe: Treatment period (12 weeks)Population: ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period)
A subject is considered as a 50% responder in POS if he/she has a \>= 50% decrease from Baseline in the POS frequency/week over Treatment period.
Outcome measures
| Measure |
Keppra®
n=79 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=79 Participants
placebo
|
|---|---|---|
|
50% Response in Weekly POS Frequency
Response
|
34 Participants
|
23 Participants
|
|
50% Response in Weekly POS Frequency
Non-Response
|
45 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: over the treatment period (12 weeks)Population: ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period).
The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.
Outcome measures
| Measure |
Keppra®
n=79 Participants
Keppra® extended release formulation (XR)
|
Placebo
n=79 Participants
placebo
|
|---|---|---|
|
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
< -25%
|
11 Participants
|
13 Participants
|
|
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
75% - <100%
|
11 Participants
|
7 Participants
|
|
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
100%
|
8 Participants
|
2 Participants
|
|
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
-25% - <25%
|
14 Participants
|
23 Participants
|
|
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
25% - <75%
|
35 Participants
|
34 Participants
|
Adverse Events
Keppra®
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Keppra®
n=77 participants at risk
Keppra® extended release formulation (XR)
|
Placebo
n=79 participants at risk
placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
1.3%
1/77 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
0.00%
0/79 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Epilepsy
|
1.3%
1/77 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
1.3%
1/77 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
0.00%
0/79 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.00%
0/77 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Simple partial seizures
|
1.3%
1/77 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
0.00%
0/79 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Stupor
|
0.00%
0/77 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/77 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
0.00%
0/79 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/77 • Number of events 1 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
0.00%
0/79 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
Other adverse events
| Measure |
Keppra®
n=77 participants at risk
Keppra® extended release formulation (XR)
|
Placebo
n=79 participants at risk
placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.2%
4/77 • Number of events 5 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
General disorders
Irritability
|
6.5%
5/77 • Number of events 5 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
0.00%
0/79 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Infections and infestations
Influenza
|
7.8%
6/77 • Number of events 7 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
5/77 • Number of events 6 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
5.1%
4/79 • Number of events 4 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Dizziness
|
5.2%
4/77 • Number of events 4 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Headache
|
6.5%
5/77 • Number of events 8 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
13.9%
11/79 • Number of events 21 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
|
Nervous system disorders
Somnolence
|
7.8%
6/77 • Number of events 7 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that 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 results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER