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

This study has been completed.
Information provided by (Responsible Party):
Ceregene Identifier:
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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 38   20   58 
[Units: Years]
Mean (Standard Deviation)
 60.1  (7.56)   57.3  (8.3)   59.1  (8.0) 
[Units: Participants]
Female   10   5   15 
Male   28   15   43 
Region of Enrollment 
[Units: Participants]
United States   38   20   58 

  Outcome Measures
  Show All Outcome Measures

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

2.  Other Pre-specified:   UPDRS Part III OFF   [ Time Frame: Change from Baseline to 18 Month Visit ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

  More Information