Recent Updates
Recently added Catalysts

CERE-120

Phase 2

Idiopathic Parkinson's Disease | Gene therapy | Neurology |Sangamo Therapeutics, Inc.|Trials Updated: Nov 10, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

CERE-120 clinical trials

CERE-120 · 1 trial · 1 indication

Phase 2 1
NCT00400634Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's Disease
COMPLETED58 Analytics
PHASE2COMPLETED
Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease
Idiopathic Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

UPDRS Part III OFF
Change from Baseline to 12 Month Visit

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.

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALIntracerebral administration of CERE-120
2SHAM_COMPARATORSham Neurosurgery

Interventions

NameTypeDescription
CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])DRUGCERE-120 5.4 x 10\^11 vg
Sham SurgeryPROCEDUREBilateral partial thickness burr holes placed, no intraparenchymal injections
Unlock Study Design Details

Eligibility Criteria

Age Range35 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

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...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about CERE-120

What is CERE-120 used for?

CERE-120 is an investigational gene therapy being developed for idiopathic Parkinson's disease. It is designed to deliver a gene to brain cells to support the survival and function of dopamine-producing neurons affected by the disease. It has been studied in a Phase 2 clinical trial and is not approved for any use.

Who is developing CERE-120?

CERE-120 is being developed by Sangamo Therapeutics, Inc., which trades on the Nasdaq under the ticker SGMO. The company is responsible for the clinical development program for the therapy in idiopathic Parkinson's disease.

What phase is CERE-120 in?

CERE-120 has completed a Phase 2 clinical trial in idiopathic Parkinson's disease. It is an investigational therapy and has not been approved by the FDA. No active trials are currently listed for CERE-120, and further development steps have not been announced.

What clinical trials has CERE-120 been studied in?

CERE-120 has been studied in one completed Phase 2 trial, NCT00400634, titled a double-blind, multicenter, sham surgery controlled study in subjects with idiopathic Parkinson's disease. The trial enrolled 58 participants in the United States and was randomized, double-blind, and sham-controlled.

Is CERE-120 the same as AAV2-neurturin?

Yes, CERE-120 is also known as AAV2-neurturin, which stands for adeno-associated virus serotype 2 delivering the neurturin gene. This is the full scientific name for the gene therapy construct used in the clinical program.