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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;   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
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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.
No text entered.

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  
Number of Participants  
[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
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Raymond T. Bartus, Executive Vice President and Cheif Scientific Officer
Organization: Ceregene, Inc.
phone: 858-458-8823

Publications of Results:

Responsible Party: Ceregene Identifier: NCT00400634     History of Changes
Other Study ID Numbers: CERE-120-02
Study First Received: November 15, 2006
Results First Received: May 24, 2012
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration