NCT00400634

Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])	CERE-120 5.4 x 10\^11 vg
PROCEDURE	Sham Surgery	Bilateral partial thickness burr holes placed, no intraparenchymal injections

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2006-11-17
• Last updated: 2022-11-10
• Results posted: 2012-08-14

Locations

9 sites across 1 country: United States