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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01044992 |
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Date of registration:
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06/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study
MSAJOY |
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Scientific title:
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Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge |
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Date of first enrolment:
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May 2002 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01044992 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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François Tison, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Name:
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Pierre Payoux, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Name:
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Olivier Rascol, MD PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Name:
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Franck Durif, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Name:
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Jean-Philippe Azulay, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Marseille |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- MSA patients will be included if they met Gilman criteria for probable MSA. All those
subjects will be distinguished between parkinsonian form (MSA-P) and cerebellar form
(MSA-C). All will underwent Unified Parkinson's Disease Rating Scale UPDRS and
International Cooperative Ataxia Rating Scale ICARSS. All patients will have a poor
response to levodopa (<30% of the UPDRS score).
- Patients with PD will be included if they suffered from idiopathic PD according to
the criteria of UKPDSBB and had a positive response to levodopa (= 30% improvement on
UPDRS part III).
- All healthy subjects will have normal neurological examination and none will have a
history of neurological, cardiovascular or psychiatric disturbance.
- For all subjects, handedness will be determined by the Edinburg test. For all
patients (MSA and PD) a MRI brain scan will be realized
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multisystemic Atrophy
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Intervention(s)
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Radiation: H215O PET
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Drug: Levodopa
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Primary Outcome(s)
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The "movement effect" consists of comparing the images obtained during hand movement with those acquired at rest for each group (MSA, PD and Healthy subjects) using the Family Wise Error (FWE) statistical threshold in OFF and ON conditions
[Time Frame: Yes]
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Secondary Outcome(s)
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Difference between motor activation during OFF and ON condition in each group reflecting levodopa effect on motor activation
[Time Frame: No]
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Difference between motor activation of the three groups in OFF condition
[Time Frame: No]
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Secondary ID(s)
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01 036 08
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PHRC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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