Trial Outcomes & Findings for Add on Lacosamide Versus High Dose Monotherapy (NCT NCT01345058)
NCT ID: NCT01345058
Last Updated: 2017-05-30
Results Overview
Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
6 Months
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Lacosamide + Low-Dose Levetiracetam
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
36
|
|
Overall Study
Received Lacosamide
|
19
|
0
|
|
Overall Study
COMPLETED
|
15
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Lacosamide + Low-Dose Levetiracetam
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Participant Reported Increase in Events
|
1
|
0
|
|
Overall Study
Side Effects of Hair Loss and Itchiness
|
1
|
0
|
|
Overall Study
Participant Stopped Taking Study Drug
|
1
|
0
|
|
Overall Study
Participant No-Show at Multiple Visits
|
1
|
0
|
Baseline Characteristics
Add on Lacosamide Versus High Dose Monotherapy
Baseline characteristics by cohort
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=20 Participants
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 Participants
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 19.8 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.
Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.
Outcome measures
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=19 Participants
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 Participants
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Percentage of Participants Achieving Six Month Seizure Freedom
|
47.4 percentage of participants
|
41.7 percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.
Outcome measures
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=19 Participants
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 Participants
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Number of Seizure-Free Days
|
118.11 days
Standard Deviation 68.59
|
114.0 days
Standard Deviation 65.06
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.
Time in days until the first seizure after the therapeutic dose is reached occurs.
Outcome measures
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=19 Participants
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 Participants
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Time to First Seizure After Therapeutic Dose is Reached
|
162.0 days
Interval 9.0 to 180.0
|
116.5 days
Interval 6.0 to 180.0
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.
Retention rate is defined as the percentage of participants who remained on the study drug after study completion.
Outcome measures
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=19 Participants
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 Participants
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Retention Rate
|
89 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.
Outcome measures
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=18 Participants
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 Participants
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
|
11 Participants
|
26 Participants
|
Adverse Events
Lacosamide + Low-Dose Levetiracetam
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Control Group (High-Dose Levetiracetam)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lacosamide + Low-Dose Levetiracetam
n=18 participants at risk
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
|
Control Group (High-Dose Levetiracetam)
n=36 participants at risk
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
0.00%
0/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
0.00%
0/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Psychiatric disorders
Irritability/depression
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
33.3%
12/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
General disorders
Fatigue
|
11.1%
2/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
19.4%
7/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
13.9%
5/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Psychiatric disorders
Memory/cognitive difficulties/confusion
|
11.1%
2/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
8.3%
3/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
11.1%
2/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
0.00%
0/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
0.00%
0/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Reproductive system and breast disorders
Decreased libido
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
0.00%
0/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
|
Cardiac disorders
Bradycardia
|
5.6%
1/18 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
0.00%
0/36 • 6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place