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


  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
  Hide Other Adverse Events

Time Frame 23 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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)

Other Adverse Events
    CERE-120 Treatment Group     Sham Surgery Control Group  
Total, other (not including serious) adverse events      
# participants affected / at risk     38/38     20/20  
Eye disorders      
Vision Blurred † 1    
# participants affected / at risk     1/38 (2.63%)     2/20 (10.00%)  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     13/38 (34.21%)     6/20 (30.00%)  
Constipation † 1    
# participants affected / at risk     4/38 (10.53%)     3/20 (15.00%)  
Diarrhoea † 1    
# participants affected / at risk     3/38 (7.89%)     1/20 (5.00%)  
Vomiting † 1    
# participants affected / at risk     3/38 (7.89%)     1/20 (5.00%)  
Dyspepsia † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     3/38 (7.89%)     1/20 (5.00%)  
Face Edema † 1    
# participants affected / at risk     2/38 (5.26%)     1/20 (5.00%)  
Gait Disturbance † 1    
# participants affected / at risk     2/38 (5.26%)     1/20 (5.00%)  
Edema † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Edema Peripheral † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Infections and infestations      
Urinary Tract Infection † 1    
# participants affected / at risk     4/38 (10.53%)     2/20 (10.00%)  
Nasopharyngitis † 1    
# participants affected / at risk     3/38 (7.89%)     1/20 (5.00%)  
Upper Respiratory Tract Infection † 1    
# participants affected / at risk     2/38 (5.26%)     2/20 (10.00%)  
Bronchitis † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Sinusitis † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     0/38 (0.00%)     2/20 (10.00%)  
Injury, poisoning and procedural complications      
Post Procedural Pain † 1    
# participants affected / at risk     11/38 (28.95%)     7/20 (35.00%)  
Headache Postoperative † 1    
# participants affected / at risk     5/38 (13.16%)     5/20 (25.00%)  
Incision Site Complication † 1    
# participants affected / at risk     6/38 (15.79%)     2/20 (10.00%)  
Fall † 1    
# participants affected / at risk     4/38 (10.53%)     2/20 (10.00%)  
Procedural Hypotension † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Investigations      
Blood Testosterone Decreased † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Musculoskeletal and connective tissue disorders      
Back Pain † 1    
# participants affected / at risk     5/38 (13.16%)     2/20 (10.00%)  
Arthralgia † 1    
# participants affected / at risk     3/38 (7.89%)     3/20 (15.00%)  
Pain in Extremity † 1    
# participants affected / at risk     5/38 (13.16%)     0/20 (0.00%)  
Shoulder Pain † 1    
# participants affected / at risk     2/38 (5.26%)     2/20 (10.00%)  
Osteoarthritis † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     28/38 (73.68%)     10/20 (50.00%)  
Dyskinesia † 1    
# participants affected / at risk     9/38 (23.68%)     6/20 (30.00%)  
Parkinson's Disease † 1    
# participants affected / at risk     8/38 (21.05%)     4/20 (20.00%)  
Dizziness † 1    
# participants affected / at risk     4/38 (10.53%)     4/20 (20.00%)  
Hypoaesthesia † 1    
# participants affected / at risk     1/38 (2.63%)     4/20 (20.00%)  
Tremor † 1    
# participants affected / at risk     2/38 (5.26%)     2/20 (10.00%)  
Freezing Phenomena † 1    
# participants affected / at risk     2/38 (5.26%)     1/20 (5.00%)  
Balance Disorder † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Brain Edema † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Cognitive Disorder † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     8/38 (21.05%)     2/20 (10.00%)  
Depression † 1    
# participants affected / at risk     4/38 (10.53%)     3/20 (15.00%)  
Anxiety † 1    
# participants affected / at risk     2/38 (5.26%)     4/20 (20.00%)  
Confusional State † 1    
# participants affected / at risk     1/38 (2.63%)     2/20 (10.00%)  
Hallucinations † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Renal and urinary disorders      
Micturation Urgency † 1    
# participants affected / at risk     4/38 (10.53%)     1/20 (5.00%)  
Hematuria † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Pollakiuria † 1    
# participants affected / at risk     2/38 (5.26%)     1/20 (5.00%)  
Urinary Incontinence † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Urinary Retention † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Renal Failure † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Rhinorrhea † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Sleep Apnea Syndrome † 1    
# participants affected / at risk     2/38 (5.26%)     0/20 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     5/38 (13.16%)     0/20 (0.00%)  
Periorbital Edema † 1    
# participants affected / at risk     3/38 (7.89%)     1/20 (5.00%)  
Pruritis † 1    
# participants affected / at risk     3/38 (7.89%)     0/20 (0.00%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     3/38 (7.89%)     2/20 (10.00%)  
Hypotension † 1    
# participants affected / at risk     2/38 (5.26%)     1/20 (5.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)



  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.


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
No text entered.  


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


Publications of Results:

Responsible Party: Ceregene
ClinicalTrials.gov 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