Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CERE-120 · 1 trial · 1 indication
The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined "off" condition, 12 hours or more after the last administration of medication.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Intracerebral administration of CERE-120 |
| 2 | SHAM_COMPARATOR | Sham Neurosurgery |
| Name | Type | Description |
|---|---|---|
| CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) | DRUG | CERE-120 5.4 x 10\^11 vg |
| Sham Surgery | PROCEDURE | Bilateral partial thickness burr holes placed, no intraparenchymal injections |
Inclusion Criteria: * Diagnosis of bilateral, idiopathic Parkinson's Disease (PD) based on UK Brain Bank criteria with motor complications despite adequate oral antiparkinsonian therapy. * At least 5 years disease duration, relative to the anticipated date of surgery, since diagnosis of PD. * Males...