Natural History of Levodopa-Induced Dyskinesia (LID)

Parkinson's Disease Clinical Trial

Official title:

Determining the Natural History of Levodopa-Induced Dyskinesia (LID)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01003002
• Other study ID #: e4773
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2009
• Last updated: April 4, 2016
• Start date: December 2010
• Est. completion date: December 2020

Study information

• Verified date: October 2009
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 100 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Levodopa (delivered intravenously)
One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Oregon Clinical and Translational Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levodopa-Induced Dyskinesia		5 years	No