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

History of Changes

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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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 ]

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2. Other Pre-specified:

UPDRS Part III OFF [ Time Frame: Change from Baseline to 18 Month Visit ]

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Serious Adverse Events

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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	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)

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