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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
58 subjects were recruited over a 10.5 month period at 11 centers in the US

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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)

Participant Flow: Overall Study

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