- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136213
Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study (SEROTAMS)
August 3, 2017 updated by: University Hospital, Bordeaux
Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study
Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis.
MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms.
Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission.
Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep.
The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease.
Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission.
During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were developed.
Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France, 33076
- CHU de Bordeaux
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Limoges, France
- Chu Limoges
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Toulouse, France, 31059
- CHU de Toulouse
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited by neurologists specialized in movement disorders
Description
Inclusion Criteria:
Patients with Multiple system atrophy (MSA)
- MSA possible or probable
- Male and female
- Age : 30 to 80
- No cognitive impairment
- Unmodified treatment for 2 months
- Able to give informed consent
- Affiliated to social insurance
Patients with idiopathic Parkinson's disease (IPD):
- Positive clinical criteria for IPD
- Male and female
- Age : 30 to 80
- No cognitive impairment
- Unmodified treatment for 2 months
- Able to give informed consent
- Affiliated to social insurance
Healthy controls:
- Absence of neuropsychiatric disorder
- Male and female
- Age : 30 to 80
- Able to give informed consent
- Affiliated to social insurance
Exclusion Criteria:
Patients with Multiple system atrophy (MSA)
- Other Parkinsonian syndrome
- Dementia
- Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors
- History of major depression
- Contraindication to brain MRI
- Contraindication to PET
Patients with idiopathic Parkinson's disease
- Other Parkinsonian syndrome
- Dementia
- Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors
- History of major depression
- Contraindication to brain MRI
- Contraindication to PET
Healthy controls:
- Patient having a neuropsychiatric disease
- Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors
- History of major depression
- Contraindication to brain MRI
- Contraindication to PET
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Idiopathic Parkinson Disease
|
5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study.
Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo.
The order of fluoxetine and placebo intake will be randomly assigned.
A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.
The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo.
The order of fluoxetine and placebo intake will be randomly assigned.
|
Multiple system atrophy
|
5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study.
Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo.
The order of fluoxetine and placebo intake will be randomly assigned.
A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.
The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo.
The order of fluoxetine and placebo intake will be randomly assigned.
|
Volunteers without neuropsychiatric disorder (Control)
|
5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study.
Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo.
The order of fluoxetine and placebo intake will be randomly assigned.
A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.
The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo.
The order of fluoxetine and placebo intake will be randomly assigned.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus
Time Frame: Second visit (day 1)
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Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in the raphe nucleus.
|
Second visit (day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18F-MPPF binding potential - Biding potential (BP) in other brain areas
Time Frame: Second visit (day 1)
|
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) in other brain areas (brainstem, hippocampus, etc.)
|
Second visit (day 1)
|
Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
Time Frame: Second visit (day 1)
|
Second visit (day 1)
|
|
18F-MPPF binding potential - Biding potential (BP) under placebo in other brain areas
Time Frame: Third visit (day 30)
|
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in other brain areas (brainstem, hippocampus, etc.).
|
Third visit (day 30)
|
18F-MPPF binding potential - BP under fluoxetine in all brain areas
Time Frame: Third visit (day 30)
|
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential - BP) after intake of fluoxetine in all brain areas.
|
Third visit (day 30)
|
Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
Time Frame: Third visit (day 30)
|
Third visit (day 30)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Igor SIBON, Pr, University Hospital Bordeaux (France)
- Study Chair: Geneviève CHENE, Pr, University Hospital Bordeaux (France)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2010
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
May 26, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Actual)
August 4, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Pathological Conditions, Anatomical
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Hypotension
- Atrophy
- Multiple System Atrophy
- Shy-Drager Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- CHUBX 2008/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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