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NCT Number: NCT01142739

Phosphorylation of ERK1/2 in Patients With Parkinson's Disease

Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and constitutes a debilitating complication of dopaminergic treatment in late stage. Among several neurobiological mechanisms identified so far, the investigators have established in experimental models the key role of D1 receptor hypersensitivity and a"Ras-ERK" signalling pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's Disease.

The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's Disease controls. Blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as well as clinical data collection will be done during a scheduled pre-op work-up (deep brain stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled using an anti-pERK antibody and mean fluorescence intensity and percent of labelled lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will be collected "on" et "off" for dosage of dopamine. The motor effect of levodopa will be assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive oculometric recordings.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux Hôpital Haut Lévêque

Pessac, 33604, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive eligible PD in- and outpatients selected at the university hospital of Bordeaux.
  • Non-demented patients (DSM IV) who are able to give their informed consent and who are affiliated to the social security.
  • Controls: Subjects without known neurological disorder, non-demented, able to give their informed consent and affiliated to the social security.

Exclusion criteria

  • Patients: Atypical or secondary parkinson disease.
  • Previous or current cancer or malignant haemopathy.
  • Known auto-immune disease.
  • Anti-neoplastic or immuno-modulator treatment (particularly corticosteroids). Immuno-deficient subjects.
  • Acute viral infection (within 2 weeks after resolving). Statin drug intake. Demented subject (DSMIV).
  • Controls: Same criteria as above plus any neurological disease.

Treatment and study plan

Clinical variables

Other

Demography, disease duration, treatment duration, current treatment, daily intake of levodopa, Disease stage (Hoehn and Yahr, HY), motor score (UPDRS III) and dyskinesia severity (UPDRS IV). Biological variables.

Primary outcomes

  1. ERK phosphorylation

    Time frame: Day 1

    Distribution of variables and difference in the state of ERK phosphorylation in two contrasted groups : the dyskinetic levodopa-treated PD group and control group.

Secondary outcomes

  1. plasma and urinary dopamine in "on" and "off" state

    Time frame: Day 1

  2. measure derivatives of morphine

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Université Victor Segalen Bordeaux 2

Registry information

Official study title

A Descriptive Study of Lymphocytic Phosphorylation of ERK1/2 in Patients With Parkinson's Disease With Dyskinesias and in Controls

Acronym: BIODYS (1)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 11, 2010
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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