Parkinson's DiseaseNCT00169364
Clinical, Molecular and Metabolic Characteristics of Parkinson's Disease (PD) Patients With Parkin Mutation
A study testing positron emission tomography in people with Parkinson's Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease have been recently identified. The monogenic form due to parkin mutation is responsible for many familial cases and sporadic forms. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- positron emission tomography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- May 2002to not given
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Juvenile Parkinson's disease (< 45 years)
- Parkin mutation
- Normal brain magnetic resonance imaging (MRI)
Who cannot join
- Contraindication to brain MRI
- Women without effective contraception
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Paris
Marie-Laure Welter, MD, 33-142161950, marie-laure.welter@psl.aphp.fr
Alexis Brice, MD, PhD
About this study
Official title: Comparison of Clinical, Molecular and Metabolic Characteristics of PD Patients With and Without Parkin Mutation
Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease have been recently identified. The monogenic form due to parkin mutation is responsible for many familial cases and sporadic forms. However, the relationship between the mutation and the genotype of patients is not fully established. The aim of this study is to compare clinical, metabolic and neuropsychological characteristics obtained in patients with parkin mutation with those of patients without parkin mutation.
- Conditions
- Parkinson's Disease
- Being tested
- positron emission tomography
- Keywords
- Parkinson's disease, parkin mutation, Juvenile parkinson's disease, positron emission tomography
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkin mutation
Motor disability
Neuropsychological evaluation
Psychiatric evaluation
Secondary outcomes (1)
Positron emission tomography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Investigators
- Alexis Brice, MD, PhD, Study director, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169364
- Sponsor's protocol ID
- P011104
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 29 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical, Molecular and Metabolic Characteristics of PD Patients With and Without Parkin Mutation
- ClinicalTrials.gov ID
- NCT00169364
- Acronym / sponsor ID
- P011104
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, parkin mutation, Juvenile parkinson's disease, positron emission tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- May 2002
- First posted
- 15 Sep 2005 (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.
Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease have been recently identified. The monogenic form due to parkin mutation is responsible for many familial cases and sporadic forms. However, the relationship between the mutation and the genotype of patients is not fully established. The aim of this study is to compare clinical, metabolic and neuropsychological characteristics obtained in patients with parkin mutation with those of patients without parkin mutation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Juvenile Parkinson's disease (< 45 years)
- Parkin mutation
- Normal brain magnetic resonance imaging (MRI)
Key exclusion criteria (2 listed)
- Contraindication to brain MRI
- Women without effective contraception
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 |
|---|---|---|
| positron emission tomography | Device | – |
Primary outcome
Parkin mutation
Motor disability
Neuropsychological evaluation
Psychiatric evaluation
1 secondary outcome
Positron emission tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2007.
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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.
Alexis Brice, MD, PhD study director
Groupe Hospitalier Pitie-Salpetriere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positron emission tomography in people with Parkinson's Disease, run by Groupe Hospitalier Pitie-Salpetriere 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 2 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: status not confirmed, as of the sponsor's last update on 29 Aug 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis Brice, MD, PhD (33-142162183, brice@ccr.jussieu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkin mutation. The study lists 4 primary outcomes in all. 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 29 Aug 2007.