Trial Outcomes & Findings for Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis (NCT NCT02939937)
NCT ID: NCT02939937
Last Updated: 2019-08-12
Results Overview
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Measured at baseline and month 1, 6
Results posted on
2019-08-12
Participant Flow
Participant milestones
| Measure |
Phenytoin
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
50
|
|
Overall Study
COMPLETED
|
15
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Phenytoin
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phenytoin
n=21 Participants
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=50 Participants
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=71 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=21 Participants
|
50 Participants
n=50 Participants
|
71 Participants
n=71 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=71 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=21 Participants
|
40 Participants
n=50 Participants
|
54 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=21 Participants
|
10 Participants
n=50 Participants
|
17 Participants
n=71 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Iran
|
15 participants
n=15 Participants • 6 subjects in phenytoin group and 3 subjects in placebo group were excluded from our study and this left 15 patients in phenytoin and 47 subjects in placebo group to be analysed.
|
47 participants
n=47 Participants • 6 subjects in phenytoin group and 3 subjects in placebo group were excluded from our study and this left 15 patients in phenytoin and 47 subjects in placebo group to be analysed.
|
62 participants
n=62 Participants • 6 subjects in phenytoin group and 3 subjects in placebo group were excluded from our study and this left 15 patients in phenytoin and 47 subjects in placebo group to be analysed.
|
PRIMARY outcome
Timeframe: Measured at baseline and month 1, 6Population: incomplete follow up from baseline to 6 month
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Outcome measures
| Measure |
Phenytoin
n=15 Participants
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=47 Participants
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Retinal Ganglion Cell Inner Plexiform Layer Thickness
baseline
|
36.56 micron
Standard Deviation 6.61
|
34.65 micron
Standard Deviation 8.49
|
|
Retinal Ganglion Cell Inner Plexiform Layer Thickness
1 month
|
31 micron
Standard Deviation 6.61
|
29.42 micron
Standard Deviation 5.98
|
|
Retinal Ganglion Cell Inner Plexiform Layer Thickness
6 months
|
30.70 micron
Standard Deviation 5.56
|
32.12 micron
Standard Deviation 9.10
|
PRIMARY outcome
Timeframe: Measured at baseline and month 1, 6Population: incomplete follow up
macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
Outcome measures
| Measure |
Phenytoin
n=15 Participants
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=47 Participants
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Macular Layer Thickness
baseline
|
262.73 micron
Standard Deviation 22.02
|
265.98 micron
Standard Deviation 22.5
|
|
Macular Layer Thickness
1 month
|
255 micron
Standard Deviation 19.72
|
264.39 micron
Standard Deviation 22.53
|
|
Macular Layer Thickness
6 months
|
269 micron
Standard Deviation 28.29
|
268.37 micron
Standard Deviation 22.69
|
PRIMARY outcome
Timeframe: at baseline and month 6Population: incomplete follow up
Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
Outcome measures
| Measure |
Phenytoin
n=15 Participants
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=47 Participants
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Best Corrected Visual Acuity
baseline
|
1.44 log mar
Standard Deviation 0.98
|
1 log mar
Standard Deviation 0.83
|
|
Best Corrected Visual Acuity
6 months
|
0.04 log mar
Standard Deviation 0.067
|
0.13 log mar
Standard Deviation 0.448
|
PRIMARY outcome
Timeframe: Measured at baseline and month 6Population: incomplete follow up
The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).
Outcome measures
| Measure |
Phenytoin
n=15 Participants
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=47 Participants
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Visual Field Mean Deviation in Decibel
Baseline visual field mean deviation (MD)
|
-17.07 db
Standard Deviation 11.41
|
-17.76 db
Standard Deviation 11.81
|
|
Visual Field Mean Deviation in Decibel
6 months MD
|
-3.89 db
Standard Deviation 4.46
|
-5.16 db
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: Measured at baseline and month1 ,6Population: incomplete follow up
Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Outcome measures
| Measure |
Phenytoin
n=15 Participants
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=47 Participants
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Retinal Nerve Fibre Layer Thickness in Micrometer
Baseline
|
131.8 micron
Standard Deviation 36.56
|
124.87 micron
Standard Deviation 47.51
|
|
Retinal Nerve Fibre Layer Thickness in Micrometer
1 month
|
93.85 micron
Standard Deviation 8.64
|
97.41 micron
Standard Deviation 23
|
|
Retinal Nerve Fibre Layer Thickness in Micrometer
6 months
|
77.7 micron
Standard Deviation 20.03
|
78.61 micron
Standard Deviation 18.97
|
Adverse Events
Phenytoin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phenytoin
n=21 participants at risk
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=50 participants at risk
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
steven johnson
|
4.8%
1/21 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
Other adverse events
| Measure |
Phenytoin
n=21 participants at risk
patients received phenytoin 100mg three time daily up to 3 months
Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
Placebo
n=50 participants at risk
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin reaction
|
19.0%
4/21 • Number of events 4 • 6 months
|
0.00%
0/50 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place