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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:
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 
Overall Participants Analyzed 
[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


  Other Adverse Events
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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 (100.00%)   20/20 (100.00%) 
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)



  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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