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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400634
First Posted: November 17, 2006
Last Update Posted: August 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ceregene
Results First Submitted: May 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (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


  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
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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