Parkinson DiseaseBIODYS (1)NCT01142739
Phosphorylation of ERK1/2 in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Clinical variables
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive eligible PD in- and outpatients selected at the university hospital of bordeaux and subjects without known neurological disorder in a community sample.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Descriptive Study of Lymphocytic Phosphorylation of ERK1/2 in Patients With Parkinson's Disease With Dyskinesias and in Controls
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.
- Conditions
- Parkinson Disease
- Being tested
- Clinical variables
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical variablesOther
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.
Clinical variablesOther
Demography, Biological variables.
Clinical variablesOther
Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease patient | levodopa-treated parkinson's disease (PD) patients Receives: Other: Clinical variables | |
| Non Parkinson's disease controls | Non Parkinson's disease controls Receives: Other: Clinical variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERK phosphorylation
Distribution of variables and difference in the state of ERK phosphorylation in two contrasted groups : the dyskinetic levodopa-treated PD group and control group.
Measured: Day 1
Secondary outcomes (2)
plasma and urinary dopamine in "on" and "off" state
Measured: Day 1
measure derivatives of morphine
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Université Victor Segalen Bordeaux 2
- Responsible party
- Sponsor
- Investigators
- Nathalie DAMON-PERRIERE, Dr., Principal investigator, University Hospital, BordeauxGeneviève CHENE, Pr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142739
- Sponsor's protocol ID
- CHUBX 2009/20
- Acronym
- BIODYS (1)
- Status last verified
- Jul 2012
- First submitted
- 1 Jun 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of Lymphocytic Phosphorylation of ERK1/2 in Patients With Parkinson's Disease With Dyskinesias and in Controls
- ClinicalTrials.gov ID
- NCT01142739
- Acronym / sponsor ID
- BIODYS (1) / CHUBX 2009/20
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Université Victor Segalen Bordeaux 2
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease patient | – | Other: Clinical variableslevodopa-treated parkinson's disease (PD) patients |
| Non Parkinson's disease controls | – | Other: Clinical variablesNon Parkinson's disease controls |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible PD in- and outpatients selected at the university hospital of bordeaux and subjects without known neurological disorder in a community sample.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical variablesDemography, 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. | Other | Parkinson's Disease patient |
| Clinical variablesDemography, Biological variables. | Other | Non Parkinson's disease controls |
| Clinical variablesEye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording) | Other | Non Parkinson's disease controls, Parkinson's Disease patient |
Primary outcome
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.
2 secondary outcomes
plasma and urinary dopamine in "on" and "off" state
Time frame: Day 1
measure derivatives of morphine
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie DAMON-PERRIERE, Dr. principal investigator
University Hospital, Bordeaux
Geneviève CHENE, Pr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERK phosphorylation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.