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Trial record 4 of 6 for:    ocular albinism

Trial of L-DOPA as a Treatment to Improve Vision in Albinism

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ClinicalTrials.gov Identifier: NCT01176435
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Albinism
Interventions Drug: Levodopa
Drug: Placebo
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo
Hide Arm/Group Description

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Period Title: Overall Study
Started 15 15 15
Completed 15 15 15
Not Completed 0 0 0
Arm/Group Title 0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo Total
Hide Arm/Group Description

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 45 participants
12.5
(3.5 to 57)
19.7
(4 to 49.3)
10.6
(4 to 18.1)
14.5
(3.5 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Female
11
  73.3%
8
  53.3%
5
  33.3%
24
  53.3%
Male
4
  26.7%
7
  46.7%
10
  66.7%
21
  46.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
0
   0.0%
1
   6.7%
2
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.7%
1
   6.7%
2
  13.3%
4
   8.9%
White
13
  86.7%
14
  93.3%
12
  80.0%
39
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 15 participants 45 participants
15 15 15 45
1.Primary Outcome
Title Improved Vision
Hide Description Binocular best-corrected visual acuity-The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart) or a card held 20 feet (6 meters) away. Special charts are used when testing at distances shorter than 20 feet (6 meters). Ranges are 20/10 vision to 20/200 vision. 20/10 being the best and 20/200 being the worse.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo
Hide Arm/Group Description:

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Overall Number of Participants Analyzed 15 15 15
Mean (95% Confidence Interval)
Unit of Measure: logMAR
0.67
(0.20 to 1.0)
0.55
(0.20 to 0.88)
0.53
(0.20 to 0.90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo
Hide Arm/Group Description

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

Solution taken orally three times a day.

Levodopa: Solution taken orally three times a day.

All-Cause Mortality
0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0.76 mg/kg L-DOPA 0.51 mg/kg L-DOPA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/15 (73.33%)      7/15 (46.67%)      5/15 (33.33%)    
Cardiac disorders       
Dizzy when standing quickly  1  2/15 (13.33%)  2 0/15 (0.00%)  0 1/15 (6.67%)  1
Endocrine disorders       
Thirsty  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders       
Loss of Appetite  1  1/15 (6.67%)  1 1/15 (6.67%)  1 1/15 (6.67%)  1
Nausea  1  1/15 (6.67%)  1 2/15 (13.33%)  2 0/15 (0.00%)  0
General disorders       
Dry mouth  1  2/15 (13.33%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Sleepiness  1  1/15 (6.67%)  1 1/15 (6.67%)  1 1/15 (6.67%)  1
Fatigue  1  2/15 (13.33%)  2 0/15 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations       
Rash  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders       
Swelling of hand  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders       
Headache  1  1/15 (6.67%)  1 2/15 (13.33%)  2 0/15 (0.00%)  0
Hyperactivity  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Twitch/Tremor  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDra
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
Name/Title: C. Gail Summers, MD
Organization: University of Minnesota
Phone: 612-625-6469
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01176435     History of Changes
Other Study ID Numbers: 0912M75653
First Submitted: August 4, 2010
First Posted: August 6, 2010
Results First Submitted: June 22, 2016
Results First Posted: May 2, 2018
Last Update Posted: May 2, 2018