Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease
This study has been completed.
Sponsor:
Ceregene
Information provided by (Responsible Party):
Ceregene
ClinicalTrials.gov Identifier:
NCT00400634
First received: November 15, 2006
Last updated: July 6, 2012
Last verified: July 2012
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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
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
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
| 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 ] |
Hide Outcome Measure 2| Measure Type | Other Pre-specified |
|---|---|
| Measure Title | UPDRS Part III OFF |
| Measure Description | The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined "off" condition, 12 hours or more after the last administration of medication. |
| Time Frame | Change from Baseline to 18 Month Visit |
| Safety Issue | No |
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. |
|---|
| Subjects who completed the 12-month double-blind posttreatment period of the study continued to undergo double-blind assessments every 3 months until the last subject had completed the end-of-study visit at month 12. The LOCF method was used to impute data at month 18 for the subjects who had blinded data through month 15. |
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) |
Measured Values
| CERE-120 Treatment Group | Sham Surgery Control Group | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
19 | 11 |
|
UPDRS Part III OFF
[units: units on a scale] Least Squares Mean ± Standard Error |
-11.96 ± -7.068 | -4.34 ± -2.479 |
No statistical analysis provided for UPDRS Part III OFF