CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00400634
NCT00400634Phase 2Completed
CompareCT.gov

Multicenter, Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects With Idiopathic Parkinson's Disease

Sangamo Therapeutics·interventional·Posted Nov 17, 2006·Updated Nov 10, 2022

In Brief

A Phase 2 clinical trial evaluating CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) and Sham Surgery for Idiopathic Parkinson's Disease. Completed, enrolled 58 participants across 9 sites.

Detailed Summary

The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Parkinson's Disease
CountriesUnited States
CollaboratorsCeregene

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2006
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.6 years ago

Interventions

CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])drug

CERE-120 5.4 x 10\^11 vg

Sham Surgeryprocedure

Bilateral partial thickness burr holes placed, no intraparenchymal injections