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
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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)

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.
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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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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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
e-mail: rtbartus@ceregene.com

Publications of Results:

Marks WJ Jr, Bartus RT, Siffert J, Davis CS, Lozano A, Boulis N, Vitek J, Stacy M, Turner D, Verhagen L, Bakay R, Watts R, Guthrie B, Jankovic J, Simpson R, Tagliati M, Alterman R, Stern M, Baltuch G, Starr PA, Larson PS, Ostrem JL, Nutt J, Kieburtz K, Kordower JH, Olanow CW. Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial. Lancet Neurol. 2010 Dec;9(12):1164-72. doi: 10.1016/S1474-4422(10)70254-4. Epub 2010 Oct 20.

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

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