Trial Outcomes & Findings for Seizure Prophylaxis in Patients With Glioma or Brain Metastasis (NCT NCT03436433)
NCT ID: NCT03436433
Last Updated: 2023-04-13
Results Overview
The primary objective of this study is to assess the impact of LCM, LEV or, no AED in patients undergoing craniotomy for suspected new, recurrent or transformed glioma (WHO Gr I-IV) or brain metastasis on ED visits and readmissions within 30 days of craniotomy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
30 days following surgery
Results posted on
2023-04-13
Participant Flow
The study opened to accrual on January 31st, 2019. Potential participants were approached and invited to participate in the study during their standard of care medical visits at the Duke Cancer Center (outpatient clinic). Enrollment was suspended during the COVID-19 pandemic, from March to August 2020. The study was finally closed to accrual on February 10, 2021.
Participant milestones
| Measure |
Lacosamide
Enrolled subjects will be randomized to receive Lacosamide.
Lacosamide: LCM 100mg twice a day.
|
Levetiracetam
Enrolled subjects will be randomized to receive Levetiracetam.
Levetiracetam: LEV 1000mg twice a day.
|
No Anti-epileptic
Enrolled subjects will be randomized to not receive anti-epileptic drugs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
Baseline characteristics by cohort
| Measure |
Lacosamide
n=1 Participants
Enrolled subjects will be randomized to receive Lacosamide.
Lacosamide: LCM 100mg twice a day.
|
Levetiracetam
n=2 Participants
Enrolled subjects will be randomized to receive Levetiracetam.
Levetiracetam: LEV 1000mg twice a day.
|
No Anti-epileptic
n=1 Participants
Enrolled subjects will be randomized to not receive anti-epileptic drugs.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
51 years
STANDARD_DEVIATION 17 • n=7 Participants
|
54 years
n=5 Participants
|
49.3 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African-American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Anxiety
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days following surgeryThe primary objective of this study is to assess the impact of LCM, LEV or, no AED in patients undergoing craniotomy for suspected new, recurrent or transformed glioma (WHO Gr I-IV) or brain metastasis on ED visits and readmissions within 30 days of craniotomy.
Outcome measures
| Measure |
Lacosamide
n=1 Participants
Enrolled subjects will be randomized to receive Lacosamide.
Lacosamide: LCM 100mg twice a day.
|
Levetiracetam
n=2 Participants
Enrolled subjects will be randomized to receive Levetiracetam.
Levetiracetam: LEV 1000mg twice a day.
|
No Anti-epileptic
n=1 Participants
Enrolled subjects will be randomized to not receive anti-epileptic drugs.
|
|---|---|---|---|
|
Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days following surgeryAdverse events related to LCM, LEV, and no drug within first 30 days after craniotomy.
Outcome measures
| Measure |
Lacosamide
n=1 Participants
Enrolled subjects will be randomized to receive Lacosamide.
Lacosamide: LCM 100mg twice a day.
|
Levetiracetam
n=2 Participants
Enrolled subjects will be randomized to receive Levetiracetam.
Levetiracetam: LEV 1000mg twice a day.
|
No Anti-epileptic
n=1 Participants
Enrolled subjects will be randomized to not receive anti-epileptic drugs.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Dizziness
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Somnolence
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Cognitive disturbance
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Nausea
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Vomiting
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Ataxia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Suicide thought
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Suicide attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Anxiety
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Irritability
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Psychosis
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
Personality change
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Lacosamide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Levetiracetam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Anti-epileptic
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lacosamide
n=1 participants at risk
Enrolled subjects will be randomized to receive Lacosamide.
Lacosamide: LCM 100mg twice a day.
|
Levetiracetam
n=2 participants at risk
Enrolled subjects will be randomized to receive Levetiracetam.
Levetiracetam: LEV 1000mg twice a day.
|
No Anti-epileptic
n=1 participants at risk
Enrolled subjects will be randomized to not receive anti-epileptic drugs.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • 30 days
|
50.0%
1/2 • 30 days
|
100.0%
1/1 • 30 days
|
|
Nervous system disorders
Somnolence
|
100.0%
1/1 • 30 days
|
100.0%
2/2 • 30 days
|
100.0%
1/1 • 30 days
|
|
Nervous system disorders
Cognitive disturbance
|
100.0%
1/1 • 30 days
|
0.00%
0/2 • 30 days
|
100.0%
1/1 • 30 days
|
|
General disorders
Nausea
|
100.0%
1/1 • 30 days
|
50.0%
1/2 • 30 days
|
0.00%
0/1 • 30 days
|
|
General disorders
Vomiting
|
100.0%
1/1 • 30 days
|
0.00%
0/2 • 30 days
|
0.00%
0/1 • 30 days
|
|
Nervous system disorders
Ataxia
|
100.0%
1/1 • 30 days
|
0.00%
0/2 • 30 days
|
0.00%
0/1 • 30 days
|
|
Psychiatric disorders
Anxiety
|
100.0%
1/1 • 30 days
|
50.0%
1/2 • 30 days
|
0.00%
0/1 • 30 days
|
|
Psychiatric disorders
Irritability
|
100.0%
1/1 • 30 days
|
50.0%
1/2 • 30 days
|
0.00%
0/1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place