Natural History of Levodopa-Induced Dyskinesia (LID)

• ClinicalTrials.gov Identifier: NCT01003002
• Recruitment Status: Withdrawn
• First Posted: October 28, 2009
• Last Update Posted: April 6, 2016
• Sponsor: Oregon Health and Science University
• Collaborator: Oregon Clinical and Translational Research Institute
• Information provided by: Oregon Health and Science University

Study Description

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.

Condition or disease	Intervention/treatment
Parkinson's Disease	Drug: Levodopa (delivered intravenously)

Detailed Description:

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Determining the Natural History of Levodopa-Induced Dyskinesia (LID)
• Study Start Date: December 2010
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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); One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.

Outcome Measures

Primary Outcome Measures :

1. Levodopa-Induced Dyskinesia [ Time Frame: 5 years ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease

Criteria

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 deficits in the feet
• Significant cognitive impairment
• Unstable medical or psychiatric conditions (including hallucinations)
• History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)

Contacts and Locations

Locations

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Oregon Clinical and Translational Research Institute

Investigators

• Principal Investigator: Kathryn Chung, MD; Oregon Health and Science University

More Information

Publications of Results:

Müller 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. Epub 2007 Apr 10.

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.

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.

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.

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.

• Responsible Party: Kathryn Chung, MD, Oregon Health & Science University
• ClinicalTrials.gov Identifier: NCT01003002
• Other Study ID Numbers: e4773
• First Posted: October 28, 2009
• Last Update Posted: April 6, 2016
• Last Verified: October 2009

Keywords provided by Oregon Health and Science University:

Parkinson's disease; Dyskinesia; Movement Disorders

Additional relevant MeSH terms:

Parkinson Disease; Dyskinesias; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Neurologic Manifestations; Levodopa; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs