Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04265209 | [18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor | PHASE3 | COMPLETED | 152 | — | — | Dec 1, 2021 | Aug 2, 2024 | Nov 17, 2025 | 16 | France |
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.
| Arm | Type | Description |
|---|---|---|
| SPECT and PET | OTHER | \[123I\]-FP-CIT SPECT imaging procedure first, then \[18F\] LBT-999 PET Imaging procedure |
| PET and SPECT | OTHER | \[18F\] LBT-999 PET imaging procedure first, then \[123I\]-FP-CIT SPECT imaging procedure |
| Name | Type | Description |
|---|---|---|
| SPECT | DRUG | \[123I\]-FP-CIT SPECT imaging procedure |
| PET | DRUG | \[18F\] LBT-999 PET imaging procedure |
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 ...