Multiple System AtrophySEROTAMSNCT01136213
Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study
A study testing PET (Positron Emission Tomography) Study and Brain MRI (magnetic resonance imaging) in people with Multiple System Atrophy, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- PET (Positron Emission Tomography) Study and Brain MRI (magnetic resonance imaging)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2010to Mar 2016
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux
Bordeaux, 33076
CHU Limoges
Limoges
CHU de Toulouse
Toulouse, 31059
About this study
Official title: 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.
- Conditions
- Multiple System Atrophy
- Being tested
- PET (Positron Emission Tomography) Study, Brain MRI (magnetic resonance imaging), Fluoxétine / Placebo
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET (Positron Emission Tomography) StudyRadiation
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.
Brain MRI (magnetic resonance imaging)Other
A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.
Fluoxétine / PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple system atrophy | Active comparator | Not described Receives: Radiation: PET (Positron Emission Tomography) Study; Other: Brain MRI (magnetic resonance imaging); Drug: Fluoxétine / Placebo |
| Idiopathic Parkinson Disease | Placebo comparator | Not described Receives: Radiation: PET (Positron Emission Tomography) Study; Other: Brain MRI (magnetic resonance imaging); Drug: Fluoxétine / Placebo |
| Volunteers without neuropsychiatric disorder (Control) | Active comparator | Not described Receives: Radiation: PET (Positron Emission Tomography) Study; Other: Brain MRI (magnetic resonance imaging); Drug: Fluoxétine / Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in the raphe nucleus.
Measured: Second visit (day 1)
Secondary outcomes (5)
18F-MPPF binding potential - Biding potential (BP) in other brain areas
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) in other brain areas (brainstem, hippocampus, etc.)
Measured: Second visit (day 1)
Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
Measured: Second visit (day 1)
18F-MPPF binding potential - Biding potential (BP) under placebo in other brain areas
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in other brain areas (brainstem, hippocampus, etc.).
Measured: Third visit (day 30)
18F-MPPF binding potential - BP under fluoxetine in all brain areas
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential - BP) after intake of fluoxetine in all brain areas.
Measured: Third visit (day 30)
Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
Measured: Third visit (day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple System AtrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor SIBON, Pr, Principal investigator, University Hospital Bordeaux (France)Geneviève CHENE, Pr, Study chair, University Hospital Bordeaux (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136213
- Sponsor's protocol ID
- CHUBX 2008/01
- Other IDs
- 2008-000485-22, 2008
- Acronym
- SEROTAMS
- Status last verified
- Aug 2017
- First submitted
- 26 May 2010
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyer M, Lamare F, Asselineau J, Foubert-Samier A, Mazere J, Zanotti-Fregonara P, Rizzo G, Delamarre A, Spampinato U, Rascol O, Pavy-Le Traon A, Tison F, Fernandez P, Sibon I, Meissner WG. Brain 5-HT1A Receptor Binding in Multiple System Atrophy: An [18 F]-MPPF PET Study. Mov Disord. 2021 Jan;36(1):246-251. doi: 10.1002/mds.28295. Epub 2020 Sep 21.
PubMed 32956556
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study
- ClinicalTrials.gov ID
- NCT01136213
- Acronym / sponsor ID
- SEROTAMS / CHUBX 2008/01
- Conditions
- Multiple System Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple system atrophy | Active comparator | Radiation: PET (Positron Emission Tomography) Study, Other: Brain MRI (magnetic resonance imaging), Drug: Fluoxétine / Placebo |
| Idiopathic Parkinson Disease | Placebo comparator | Radiation: PET (Positron Emission Tomography) Study, Other: Brain MRI (magnetic resonance imaging), Drug: Fluoxétine / Placebo |
| Volunteers without neuropsychiatric disorder (Control) | Active comparator | Radiation: PET (Positron Emission Tomography) Study, Other: Brain MRI (magnetic resonance imaging), Drug: Fluoxétine / Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with Multiple system atrophy (MSA)
- Patients with idiopathic Parkinson's disease (IPD):
- Healthy controls:
Key exclusion criteria (20 listed)
- Patients with Multiple system atrophy (MSA)
- Patients with idiopathic Parkinson's disease
- Healthy controls:
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 |
|---|---|---|
| PET (Positron Emission Tomography) Study5-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. | Radiation | Idiopathic Parkinson Disease, Multiple system atrophy, Volunteers without neuropsychiatric disorder (Control) |
| Brain MRI (magnetic resonance imaging)A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study. | Other | Idiopathic Parkinson Disease, Multiple system atrophy, Volunteers without neuropsychiatric disorder (Control) |
| Fluoxétine / PlaceboThe 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. | Drug | Idiopathic Parkinson Disease, Multiple system atrophy, Volunteers without neuropsychiatric disorder (Control) |
Primary outcome
18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus
Time frame: Second visit (day 1)
Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in the raphe nucleus.
5 secondary outcomes
18F-MPPF binding potential - Biding potential (BP) in other brain areas
Time frame: Second visit (day 1)
Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
Time frame: Second visit (day 1)
18F-MPPF binding potential - Biding potential (BP) under placebo in other brain areas
Time frame: Third visit (day 30)
18F-MPPF binding potential - BP under fluoxetine in all brain areas
Time frame: Third visit (day 30)
Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
Time frame: Third visit (day 30)
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 9 Jun 2026.
- Results publication: PubMed 32956556Meyer M, Lamare F, Asselineau J, Foubert-Samier A, Mazere J, Zanotti-Fregonara P, Rizzo G, Delamarre A, Spampinato U, Rascol O, Pavy-Le Traon A, Tison F, Fernandez P, Sibon I, Meissner WG. Brain 5-HT1A Receptor Binding in Multiple System Atrophy: An [18 F]-MPPF PET Study. Mov Disord. 2021 Jan;36(1):246-251. doi: 10.1002/mds.28295. Epub 2020 Sep 21.
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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.
Igor SIBON, Pr principal investigator
University Hospital Bordeaux (France)
Geneviève CHENE, Pr study chair
University Hospital Bordeaux (France)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET (Positron Emission Tomography) Study and Brain MRI (magnetic resonance imaging) in people with Multiple System Atrophy, run by University Hospital, Bordeaux at 3 sites 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 22 inclusion and 20 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus (time frame: Second visit (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136213, which also lists 1 linked publication.
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 9 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.