Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04265209
Other study ID # ZX-2018-LBT999-DATTEP-3
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2021
Est. completion date December 2024

Study information

Verified date April 2024
Source Zionexa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical study to demonstrate an at least equivalent performance of a new PET molecular Imaging radiopharmaceutical named [18F] LBT-999 in brain imaging compared to the SPECT reference method named [123I]-FP-CIT to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 35 Years to 80 Years
Eligibility Inclusion Criteria: - Patients aged 35 to 80 (male or female) - Patients: - suffering from an essential tremor as defined by Elble's criteria from 2000 (excluding head tremor in decubitus and compatible with the study by the investigator) - or with Parkinson's disease as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) - Patients diagnosed over 18 months ago - Women of childbearing potential who must have effective contraception at baseline and up to 30 days after the last administration of the radiopharmaceutical (investigational medicinal product or comparator) - Patients affiliated with or receiving a social security scheme - Patients who have been fully informed about the organization of the research and who have signed their informed consent Exclusion Criteria: - Patients with atypical non-idiopathic Parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.) - Patients treated with deep brain stimulation - Patients with functional psychogenic movements - Patients with severe and progressive psychiatric disorders - Patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies - Patients who have had an ionizing radiation examination on the brain within the last 3 months - Individuals with a contraindication to PET or SPECT imaging: - Patients with claustrophobia - Patients refusing to be informed in case of abnormalities detected during imaging tests - Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline - Individuals with a known allergy to the active substance or one of the excipients of the product under investigation or to the reference product or to or to thyroid treatment - Woman of childbearing age without effective contraception in the opinion of the investigator - Any other serious unstabilized chronic condition deemed incompatible with the study by the investigator - Patients unable to sign the informed consent - Patients participating in a protocol or in a period of exclusion from a protocol - Patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies - Patients in a period of exclusion from the national volunteer database during which they cannot participate in another clinical study - Patients not affiliated with a social security scheme - Patients refusing to participate - Individuals referred to in articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SPECT
[123I]-FP-CIT SPECT imaging procedure
PET
[18F] LBT-999 PET imaging procedure

Locations

Country Name City State
France Hôpital Avicenne Bobigny
France CHU Bordeaux Bordeaux
France Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU) Clermont-Ferrand
France Hôpital Henri Mondor Créteil
France CLCC Georges-François Leclerc C.G.F.L Dijon
France Hôpital Roger Salengro (CHRU de Lille) Lille
France Hospices Civils de Lyon Lyon
France CHU La Timone Marseille
France Hôpital Brabois / Hôpital Central (CHRU Nancy) Nancy
France Hôpital Laennec (CHU Nantes) Nantes
France Centre Hospitalier Universitaire de Nîmes Nîmes
France CHU La Pitié Salpêtrière Paris
France Centre Eugène Marquis / CHU Pontchaillou Rennes
France Institut de cancérologie Strasbourg Europe Strasbourg
France Hôpital Pierre Paul Riquet - Purpan (CHU) Toulouse
France CHRU Hôpital Bretonneau Tours

Sponsors (1)

Lead Sponsor Collaborator
Zionexa

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity by visual analysis Sensitivity and specificity of each imaging method on the diagnosis of normal or pathological examination on the visual analysis by 5 independent readers interpreting a minimum of 200 [123I]-FP/CIT SPECT per year, without knowing the clinical diagnosis. The independent review committee will analyse the PET and SPECT images blindly. These analyses will be done by batch of 25 patients. Outcome will be assessed at the end of the study, an average of 2 years after first patient in.
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A