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Natural History of Levodopa-Induced Dyskinesia (LID)

This study has been withdrawn prior to enrollment.
(Funding not secured.)
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01003002
First received: October 27, 2009
Last updated: September 11, 2012
Last verified: October 2009

October 27, 2009
September 11, 2012
December 2010
December 2020   (final data collection date for primary outcome measure)
Levodopa-Induced Dyskinesia [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01003002 on ClinicalTrials.gov Archive Site
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Not Provided
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Natural History of Levodopa-Induced Dyskinesia (LID)
Determining the Natural History of Levodopa-Induced Dyskinesia (LID)

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.

Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Parkinson's disease

Parkinson's Disease
Drug: Levodopa (delivered intravenously)
One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.
PD Cohort
The cohort for this study is Parkinson's disease patients that are begining oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa.
Intervention: Drug: Levodopa (delivered intravenously)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Unable to stand for 1 minute intervals
  • Sensory deficites in the feet
  • Significant cognitive impairment
  • Unstable medical or psychiatric conditons (including hallucinations)
  • History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01003002
e4773
No
Kathryn Chung, MD, Oregon Health & Science University
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Principal Investigator: Kathryn Chung, MD Oregon Health and Science University
Oregon Health and Science University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP