Trial Outcomes & Findings for Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study (NCT NCT00581893)
NCT ID: NCT00581893
Last Updated: 2021-07-01
Results Overview
Number of subjects who had a crash event during the driving simulator test.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
1 month
Results posted on
2021-07-01
Participant Flow
Participant milestones
| Measure |
Phenytoin First, Then Placebo
Subjects first received Phenytoin target dose of 5 mg/kg qhs for one month. After a 14 day washout period, they received the placebo treatment for one month.
|
Placebo First, Then Phentoin
Subjects first received Placebo for one month. After a 14 day washout period, they received Phenytoin target dose of 5 mg/kg qhs for one month.
|
|---|---|---|
|
First Intervention (1 Month)
STARTED
|
10
|
10
|
|
First Intervention (1 Month)
COMPLETED
|
10
|
10
|
|
First Intervention (1 Month)
NOT COMPLETED
|
0
|
0
|
|
Washout (14 Days)
STARTED
|
10
|
10
|
|
Washout (14 Days)
COMPLETED
|
10
|
10
|
|
Washout (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Month)
STARTED
|
10
|
10
|
|
Second Intervention (1 Month)
COMPLETED
|
7
|
8
|
|
Second Intervention (1 Month)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Phenytoin First, Then Placebo
Subjects first received Phenytoin target dose of 5 mg/kg qhs for one month. After a 14 day washout period, they received the placebo treatment for one month.
|
Placebo First, Then Phentoin
Subjects first received Placebo for one month. After a 14 day washout period, they received Phenytoin target dose of 5 mg/kg qhs for one month.
|
|---|---|---|
|
Second Intervention (1 Month)
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cross-over Design
n=20 Participants
Subjects will be studied on two occasions, in random order. They will randomly be assigned to received either Phenytoin target dose of 5 mg/kg qhs for one month or placebo treatment for one month. After a 14 day washout period, they will receive the opposite treatment from the original.
|
|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 12.7 • n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 monthNumber of subjects who had a crash event during the driving simulator test.
Outcome measures
| Measure |
Phenytoin
n=20 Participants
Phenytoin target dose of 5 mg/kg
|
Placebo
n=20 Participants
Placebo oral capsule
|
|---|---|---|
|
Number of Subjects Who Had a Driving Simulator Crash Event
|
2 Participants
|
0 Participants
|
Adverse Events
Phenytoin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place