Trial Outcomes & Findings for Antiepileptic Drugs and Vascular Risk Markers (NCT NCT00774306)
NCT ID: NCT00774306
Last Updated: 2017-12-18
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
8 weeks, 16 weeks
Results posted on
2017-12-18
Participant Flow
Participant milestones
| Measure |
Phenytoin
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.
x
x
|
Valproate
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
Levetiracetam
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
|
No Anticonvulsant
Participants randomized to Group 4 will receive no drug intervention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
5
|
16
|
7
|
|
Overall Study
COMPLETED
|
6
|
3
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
18
|
2
|
8
|
5
|
Reasons for withdrawal
| Measure |
Phenytoin
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.
x
x
|
Valproate
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
Levetiracetam
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
|
No Anticonvulsant
Participants randomized to Group 4 will receive no drug intervention.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
4
|
5
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Antiepileptic Drugs and Vascular Risk Markers
Baseline characteristics by cohort
| Measure |
Phenytoin
n=24 Participants
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
|
Valproate
n=5 Participants
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
Levetiracetam
n=16 Participants
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
|
No Anticonvulsant
n=7 Participants
Participants randomized to Group 4 will receive no drug intervention.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.5 years
n=5 Participants
|
46 years
n=7 Participants
|
51 years
n=5 Participants
|
49 years
n=4 Participants
|
48 years
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
7 participants
n=4 Participants
|
52 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeks, 16 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks, 16 weeksOutcome measures
Outcome data not reported
Adverse Events
Phenytoin
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Valproate
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Levetiracetam
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
No Anticonvulsant
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phenytoin
n=24 participants at risk
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.
x
x
|
Valproate
n=5 participants at risk
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
Levetiracetam
n=16 participants at risk
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
|
No Anticonvulsant
n=7 participants at risk
Participants randomized to Group 4 will receive no drug intervention.
|
|---|---|---|---|---|
|
Nervous system disorders
vasospasm
|
4.2%
1/24
|
20.0%
1/5
|
12.5%
2/16
|
14.3%
1/7
|
|
Vascular disorders
deep venous thrombosis
|
4.2%
1/24
|
0.00%
0/5
|
6.2%
1/16
|
0.00%
0/7
|
|
Nervous system disorders
hydrocephalus
|
4.2%
1/24
|
0.00%
0/5
|
6.2%
1/16
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.00%
0/24
|
0.00%
0/5
|
0.00%
0/16
|
14.3%
1/7
|
|
Immune system disorders
drug fever
|
4.2%
1/24
|
0.00%
0/5
|
0.00%
0/16
|
0.00%
0/7
|
|
Nervous system disorders
cerebral infarction
|
0.00%
0/24
|
0.00%
0/5
|
0.00%
0/16
|
14.3%
1/7
|
Other adverse events
| Measure |
Phenytoin
n=24 participants at risk
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.
x
x
|
Valproate
n=5 participants at risk
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
Levetiracetam
n=16 participants at risk
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
|
No Anticonvulsant
n=7 participants at risk
Participants randomized to Group 4 will receive no drug intervention.
|
|---|---|---|---|---|
|
Infections and infestations
urinary tract infection
|
0.00%
0/24
|
20.0%
1/5
|
0.00%
0/16
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place