Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CERE-120: Adeno-Associated Virus Delivery of Neurturin · 1 trial · 1 indication
Number of Participants who received CERE-120 Treatment
UPDRS is a tool to evaluate the impact of symptomatic and potential disease modifying treatments. Part III focuses on 14 motor functions, assessing each on a scale from 0 (normal) to 4 (severe) with total score 0 - 56. The 5 Feb 2003 version of the UPDRS Rating was used in this trial. The total score is the sum of 14 motor functions. Change from baseline in total score is reported. The last double blind assessment for each subject is defined as the most recent assessment at the time when the final randomized subject completes the Month 15 Visit. The length of the double-blind follow-up period for each subject ranged from 15 to 24 months, depending on the enrollment rate.
| Arm | Type | Description |
|---|---|---|
| Phase 1: Cohort 1 | EXPERIMENTAL | CERE-120 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen |
| Phase 1: Cohort 2 | EXPERIMENTAL | CERE-120 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen |
| Phase 2: CERE-120 | EXPERIMENTAL | CERE-120 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen |
| Phase 2: Sham Surgery | SHAM_COMPARATOR | Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections were administered during sham surgery. |
| Name | Type | Description |
|---|---|---|
| CERE-120: Adeno-Associated Virus Delivery of Neurturin | BIOLOGICAL | - |
| Sham Surgery | PROCEDURE | - |
Inclusion Criteria: * Males and females, ages 35 to 70 years old (inclusive) * A diagnosis of idiopathic Parkinson's disease based on UK Brain Bank criteria, including bradykinesia and at least 1 of the following PD features: resting tremor or rigidity * A Hoehn and Yahr score of no greater than 3 ...