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Vision Response to Dopamine Replacement

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ClinicalTrials.gov Identifier: NCT01663935
Recruitment Status : Terminated (Lack of funding)
First Posted : August 14, 2012
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Albinism
Oculocutaneous Albinism
Intervention Drug: Levodopa/carbidopa
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levodopa/Carbidopa 4mg/kg/Day
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Levodopa/Carbidopa 4mg/kg/Day
Hide Arm/Group Description

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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
15
  75.0%
Between 18 and 65 years
5
  25.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 20 participants
Non hispanic or latino/ white
16
  80.0%
non hispanic or latino/ asian
3
  15.0%
hispanic or latino
1
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
United States 19
Canada 1
1.Primary Outcome
Title Visual Acuity Change
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants pre and post treatment per protocol
Arm/Group Title Levodopa/Carbidopa 4mg/kg/Day
Hide Arm/Group Description:

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 Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: logMar
.774  (.207)
2.Other Pre-specified Outcome
Title Contrast Sensitivity
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levodopa/Carbidopa 4mg/kg/Day
Hide Arm/Group Description:

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 Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
38
Mean (Standard Deviation)
Unit of Measure: score on a scale
23.7  (21.6)
Time Frame Adverse event data was collected for each patient starting at baseline through the month 4 study follow up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levodopa/Carbidopa 4mg/kg/Day
Hide Arm/Group Description

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.

All-Cause Mortality
Levodopa/Carbidopa 4mg/kg/Day
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Levodopa/Carbidopa 4mg/kg/Day
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levodopa/Carbidopa 4mg/kg/Day
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Michael Struck
Organization: University of Wisconsin, Madison
Phone: 608 263-6429
EMail: mcstruck@wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01663935     History of Changes
Other Study ID Numbers: 2016-1576
2012-0023 ( Other Identifier: Study team )
First Submitted: August 9, 2012
First Posted: August 14, 2012
Results First Submitted: April 9, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019