Study to demonstrate an at least equivalent performance of a new test in brain imaging test compared to the reference examination to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.
- Conditions
- Patients suffering from an essential tremor or with Parkinson's disease.MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10015496Term: Essential tremorSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2019-000247-27-FR
- Lead Sponsor
- ZIONEXA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 112
• Patient aged 35 to 80 (male or female)
• Patient:
- suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor)
- or with Parkinson's disease according to UKPDSBB criteria
• Patient whose diagnosis is more than 18 months old
• Patient affiliated with a health protection system or beneficiary of such a system
• Patient who has received complete information on the organization of the research and signed his informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Patient with atypical non-idiopathic parkinsonian syndrome (multisystematous atrophy, progressive supranuclear palsy, etc.)
• Patient treated with deep brain stimulation
• Patient suffering from abnormal functional psychogenic movements
• Patient with severe and progressive psychiatric disorders
• Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams
• Patient who had an ionizing examination at the cerebral level less than 3 months old
• Person with a contraindication to performing PET or SPECT imaging:
o Patient with claustrophobia
o Patient refusing to be informed in case of abnormalities detected during imaging examinations
o Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
o Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide
• A woman of childbearing potential who does not have effective contraception according to investigator judgment
• Patient unable to sign the informed consent
• Patient participating to a protocol or period of exclusion from a protocol
• Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies
• Patient in exclusion period in national volunteer file during which he can not participate in another clinical study
• Patient not affiliated to a health protection system
• Patient refusing to participate
• Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code:
o Pregnant or lactating woman
o Person deprived of liberty by a judicial or administrative decision,
o Person under psychiatric care
o Person admitted to a health or social institution for purposes other than research
o Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice)
o Major person unable to express consent and who is not subject to a legal protection measure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method