NCT01663935

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2019

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

5.5 years

First QC Date

August 9, 2012

Results QC Date

April 9, 2019

Last Update Submit

May 17, 2019

Conditions

AlbinismOculocutaneous Albinism

Keywords

levodopaAlbinismdopamineoculocutaneous albinismvisionretina function

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity Change

    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.

    3 months

Other Outcomes (1)

  • Contrast Sensitivity

    3 months

Study Arms (1)

Levodopa/carbidopa 4mg/kg/day

OTHER

Treatment drug taken orally three times daily

Drug: Levodopa/carbidopa

Interventions

Levodopa/carbidopaDRUG

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.

Also known as: Sinemet, Atamet, Parcopa
Levodopa/carbidopa 4mg/kg/day

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of oculocutaneous albinism
  • age over 3 and weight over 25 lbs.

You may not qualify if:

  • ocular only albinism
  • ocular pathology other than albinism
  • neurologic disease, history of myocardial infarction, history of clinical depression, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

AlbinismAlbinism, Oculocutaneous

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsSkin Diseases, GeneticHypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr Michael Struck
Organization
University of Wisconsin, Madison
mcstruck@wisc.edu
608 263-6429

Study Officials

  • Michael C Struck, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 14, 2012

Study Start

October 17, 2012

Primary Completion

April 12, 2018

Study Completion

April 12, 2018

Last Updated

June 11, 2019

Results First Posted

June 11, 2019

Record last verified: 2019-05

Locations

US(1)