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
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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
    CERE-120 Treatment Group     Sham Surgery Control Group  
STARTED     38     20  
COMPLETED     34     19  
NOT COMPLETED     4     1  



  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
  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
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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
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Time Frame 23 months
Additional Description 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)

Serious Adverse Events
    CERE-120 Treatment Group     Sham Surgery Control Group  
Total, serious adverse events      
# participants affected / at risk     13/38 (34.21%)     4/20 (20.00%)  
Cardiac disorders      
Chest Pain † 1    
# participants affected / at risk     0/38 (0.00%)     1/20 (5.00%)  
# events     0     1  
Gastrointestinal disorders      
Gastroenteritis † 1    
# participants affected / at risk     0/38 (0.00%)     1/20 (5.00%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
spinal compression fracture † 1 [3]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Lumbar Stenosis † 1 [4]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Nerve Root Compression † 1 [4]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Glioblastoma † 1 [4]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Prostate Cancer † 1 [4]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Esophageal Cancer † 1 [4]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Neoplasm Progression † 1    
# participants affected / at risk     0/38 (0.00%)     1/20 (5.00%)  
# events     0     1  
Nervous system disorders      
Cerebral Hemorrhage † 1 [5]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Gait Disturbance † 1 [3]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Fall † 1    
# participants affected / at risk     0/38 (0.00%)     1/20 (5.00%)  
# events     0     1  
Renal and urinary disorders      
Urinary Retention † 1 [4]    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
# events     2     0  
Surgical and medical procedures      
Device Failure † 1 [4]    
# participants affected / at risk     1/38 (2.63%)     0/20 (0.00%)  
# events     1     0  
Vascular disorders      
Death † 1 [6]    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
# events     2     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)
[3] Not considered related to CERE-120
[4] Considered not related to CERE-120
[5] Considered not related to CERE-120, Related to surgical procedure
[6] Neither death was considered related to CERE-120




  Other Adverse Events


  Limitations and Caveats


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