[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT04265209
• Date of registration: 06/02/2020
• Prospective Registration: Yes
• Primary sponsor: Zionexa
• Public title: [18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor
• Scientific title: Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.
• Date of first enrolment: December 1, 2021
• Target sample size: 152
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04265209
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Essential Tremor

Intervention(s)

Drug: PET

Drug: SPECT

Primary Outcome(s)

Sensitivity and specificity by visual analysis [Time Frame: 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.]

Secondary ID(s)

ZX-2018-LBT999-DATTEP-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors