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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ceregene

ClinicalTrials.gov Identifier:

NCT00400634

First received: November 15, 2006

Last updated: July 6, 2012

Last verified: July 2012

Results First Received: May 24, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Idiopathic Parkinson's Disease
Interventions:	Genetic: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Procedure: Sham Surgery

Participant Flow

Baseline Characteristics

Reporting Groups

	Description
CERE-120 Treatment Group	Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
Sham Surgery Control Group	Subjects who were randomized to undergo sham surgery (partial burr holes)
Total	Total of all reporting groups

Baseline Measures

	CERE-120 Treatment Group	Sham Surgery Control Group	Total
Number of Participants [units: participants]	38	20	58
Age [units: years] Mean ± Standard Deviation	60.1 ± 7.56	57.3 ± 8.3	59.1 ± 8.0
Gender [units: participants]
Female	10	5	15
Male	28	15	43
Region of Enrollment [units: participants]
United States	38	20	58

Outcome Measures

1. Primary:

UPDRS Part III OFF [ Time Frame: Change from Baseline to 12 Month Visit ]

Show Outcome Measure 1

2. Other Pre-specified:

UPDRS Part III OFF [ Time Frame: Change from Baseline to 18 Month Visit ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information