NCT01003002

Brief Summary

Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 6, 2016

Status Verified

October 1, 2009

Enrollment Period

10 years

First QC Date

October 27, 2009

Last Update Submit

April 4, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseDyskinesiaMovement Disorders

Outcome Measures

Primary Outcomes (1)

  • Levodopa-Induced Dyskinesia

    5 years

Study Arms (1)

PD Cohort

The cohort for this study is Parkinson's disease patients that are beginning oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa.

Drug: Levodopa (delivered intravenously)

Interventions

Levodopa (delivered intravenously)DRUG

One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.

PD Cohort

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's disease

You may qualify if:

  • Diagnosis of Parkinson's disease
  • At least 21 years of age
  • Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.

You may not qualify if:

  • Unable to stand for 1 minute intervals
  • Sensory deficits in the feet
  • Significant cognitive impairment
  • Unstable medical or psychiatric conditions (including hallucinations)
  • History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (5)

  • Muller T, Woitalla D, Russ H, Hock K, Haeger DA. Prevalence and treatment strategies of dyskinesia in patients with Parkinson's disease. J Neural Transm (Vienna). 2007;114(8):1023-6. doi: 10.1007/s00702-007-0718-4. Epub 2007 Apr 10.

    PMID: 17417738RESULT

  • Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: A randomized controlled trial. Parkinson Study Group. JAMA. 2000 Oct 18;284(15):1931-8. doi: 10.1001/jama.284.15.1931.

    PMID: 11035889RESULT

  • Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.

    PMID: 10816186RESULT

  • Nutt JG, Carter JH, Lea ES, Sexton GJ. Evolution of the response to levodopa during the first 4 years of therapy. Ann Neurol. 2002 Jun;51(6):686-93. doi: 10.1002/ana.10189.

    PMID: 12112073RESULT

  • McColl CD, Reardon KA, Shiff M, Kempster PA. Motor response to levodopa and the evolution of motor fluctuations in the first decade of treatment of Parkinson's disease. Mov Disord. 2002 Nov;17(6):1227-34. doi: 10.1002/mds.10244.

    PMID: 12465061RESULT

MeSH Terms

Conditions

Parkinson DiseaseDyskinesiasMovement Disorders

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Kathryn Chung, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

December 1, 2010

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 6, 2016

Record last verified: 2009-10

Locations

US(1)