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NCT01663935

Vision Response to Dopamine Replacement

Terminated Phase 2 Results posted Last updated 11 June 2019
What this trial tests

Phase 2 trial testing Levodopa/carbidopa in Albinism in 20 participants. Terminated before completion.

Timeline
17 October 2012
Primary endpoint
12 April 2018
12 April 2018

Quick facts

Lead sponsorUniversity of Wisconsin, Madison
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date17 October 2012
Primary completion12 April 2018
Estimated completion12 April 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Wisconsin, Madison

Who can join

3 and older, any sex, with Albinism or Oculocutaneous Albinism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Acuity Change Primary · 3 months

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.

GroupValue95% CI
Levodopa/Carbidopa 4mg/kg/Day.774± .207
Contrast Sensitivity Secondary · 3 months

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.

GroupValue95% CI
Levodopa/Carbidopa 4mg/kg/Day23.7± 21.6

Sponsor's own description

The purpose of the study is to evaluate and document physiologic and functional changes in visual performance and retinal function of patients diagnosed with albinism (a dopamine deficiency state) following a trial of oral Levodopa/carbidopa treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Levodopa/carbidopa

Trials testing the same drug.

Other recruiting trials for Albinism

Currently open trials in the same condition.

Other University of Wisconsin, Madison trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01663935.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing