Trial Outcomes & Findings for Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy (NCT NCT01673282)
NCT ID: NCT01673282
Last Updated: 2016-11-15
Results Overview
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
Recruitment status
COMPLETED
Target enrollment
315 participants
Primary outcome timeframe
From Baseline (Day 0) to 6 months
Results posted on
2016-11-15
Participant Flow
This study started to enroll subjects in Austria and Germany in July 2012 and concluded in July 2015.
The Participant Flow consists of subjects in the Safety Set (SS) which received at least 1 dose of VIMPAT. Of the 315 enrolled subjects 311 were included in the SS.
Participant milestones
| Measure |
Vimpat + Na Channel Blocking AED
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
|
Vimpat + Non-Na Channel Blocking AED
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
158
|
|
Overall Study
COMPLETED
|
120
|
132
|
|
Overall Study
NOT COMPLETED
|
33
|
26
|
Reasons for withdrawal
| Measure |
Vimpat + Na Channel Blocking AED
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
|
Vimpat + Non-Na Channel Blocking AED
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
|
|---|---|---|
|
Overall Study
Adverse Drug Reaction - Vimpat
|
9
|
5
|
|
Overall Study
Lack of Efficacy
|
9
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Other
|
1
|
6
|
Baseline Characteristics
Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
Baseline characteristics by cohort
| Measure |
Vimpat + Na Channel Blocking AED
n=153 Participants
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
|
Vimpat + Non-Na Channel Blocking AED
n=158 Participants
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
|
Total Title
n=311 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
135 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 0) to 6 monthsPopulation: The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
Outcome measures
| Measure |
Vimpat + Na Channel Blocking AED
n=149 Participants
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
|
Vimpat + Non-Na Channel Blocking AED
n=153 Participants
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
|
|---|---|---|
|
The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)
|
-15.0 percent change of ratio in dose
Standard Deviation 64.8
|
-4.4 percent change of ratio in dose
Standard Deviation 31.9
|
Adverse Events
Vimpat + Na Channel Blocking AED
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Vimpat + Non-Na Channel Blocking AED
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vimpat + Na Channel Blocking AED
n=153 participants at risk
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
|
Vimpat + Non-Na Channel Blocking AED
n=158 participants at risk
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Nervous system disorders
Seizure
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
General disorders
Adverse event
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Psychiatric disorders
Suicidal ideation
|
0.65%
1/153 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.00%
0/158 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/153 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
0.63%
1/158 • Number of events 1 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
Other adverse events
| Measure |
Vimpat + Na Channel Blocking AED
n=153 participants at risk
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
|
Vimpat + Non-Na Channel Blocking AED
n=158 participants at risk
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
|
|---|---|---|
|
General disorders
Drug ineffective
|
5.9%
9/153 • Number of events 9 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
1.3%
2/158 • Number of events 2 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Injury, poisoning and procedural complications
Off label use
|
9.8%
15/153 • Number of events 16 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
4.4%
7/158 • Number of events 7 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
|
Injury, poisoning and procedural complications
Overdose
|
9.8%
15/153 • Number of events 16 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
4.4%
7/158 • Number of events 7 • During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
|
Additional Information
UCB (Study Director)
UCB Cares
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60