Trial Outcomes & Findings for Vision Response to Dopamine Replacement (NCT NCT01663935)
NCT ID: NCT01663935
Last Updated: 2019-06-11
Results Overview
Change in visual acuity from baseline to 3 months as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP). logMar lower values equals better visual outcome.
TERMINATED
PHASE2
20 participants
3 months
2019-06-11
Participant Flow
Participant milestones
| Measure |
Levodopa/Carbidopa 4mg/kg/Day
Treatment drug taken orally three times daily
Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vision Response to Dopamine Replacement
Baseline characteristics by cohort
| Measure |
Levodopa/Carbidopa 4mg/kg/Day
n=20 Participants
Treatment drug taken orally three times daily
Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
|
|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non hispanic or latino/ white
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · non hispanic or latino/ asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · hispanic or latino
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: participants pre and post treatment per protocol
Change in visual acuity from baseline to 3 months as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP). logMar lower values equals better visual outcome.
Outcome measures
| Measure |
Levodopa/Carbidopa 4mg/kg/Day
n=19 Participants
Treatment drug taken orally three times daily
Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
|
|---|---|
|
Visual Acuity Change
|
.774 logMar
Standard Deviation .207
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: participants pre and post medication per protocol for contrast sensitivity. Range could be anywhere from a score of 0 to 75 for each eye. The higher the score the more letters they could see in low contrast.
Ancillary testing of visual/retinal function with contrast sensitivity testing. Contrast sensitivity testing measures how well the eyes can distinguish between finer and finer light increments compared to dark. This test is a chart with different capital letters organized in horizontal lines. The contrast decreases with each line. The person will move down the chart to determine the least level of contrast they can see.
Outcome measures
| Measure |
Levodopa/Carbidopa 4mg/kg/Day
n=38 eyes
Treatment drug taken orally three times daily
Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
|
|---|---|
|
Contrast Sensitivity
|
23.7 score on a scale
Standard Deviation 21.6
|
Adverse Events
Levodopa/Carbidopa 4mg/kg/Day
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