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 |
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
Serious Adverse Events| Time Frame | 23 months |
|---|---|
| Additional Description | 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) |
Serious Adverse Events
| CERE-120 Treatment Group | Sham Surgery Control Group | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected / at risk | 13/38 (34.21%) | 4/20 (20.00%) |
| Cardiac disorders | ||
| Chest Pain † 1 | ||
| # participants affected / at risk | 0/38 (0.00%) | 1/20 (5.00%) |
| # events | 0 | 1 |
| Gastrointestinal disorders | ||
| Gastroenteritis † 1 | ||
| # participants affected / at risk | 0/38 (0.00%) | 1/20 (5.00%) |
| # events | 0 | 1 |
| Musculoskeletal and connective tissue disorders | ||
| spinal compression fracture † 1 [3] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Lumbar Stenosis † 1 [4] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Nerve Root Compression † 1 [4] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Glioblastoma † 1 [4] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Prostate Cancer † 1 [4] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Esophageal Cancer † 1 [4] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Neoplasm Progression † 1 | ||
| # participants affected / at risk | 0/38 (0.00%) | 1/20 (5.00%) |
| # events | 0 | 1 |
| Nervous system disorders | ||
| Cerebral Hemorrhage † 1 [5] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Gait Disturbance † 1 [3] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Fall † 1 | ||
| # participants affected / at risk | 0/38 (0.00%) | 1/20 (5.00%) |
| # events | 0 | 1 |
| Renal and urinary disorders | ||
| Urinary Retention † 1 [4] | ||
| # participants affected / at risk | 2/38 (5.26%) | 0/20 (0.00%) |
| # events | 2 | 0 |
| Surgical and medical procedures | ||
| Device Failure † 1 [4] | ||
| # participants affected / at risk | 1/38 (2.63%) | 0/20 (0.00%) |
| # events | 1 | 0 |
| Vascular disorders | ||
| Death † 1 [6] | ||
| # participants affected / at risk | 2/38 (5.26%) | 0/20 (0.00%) |
| # events | 2 | 0 |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA (10.0) |
| [3] | Not considered related to CERE-120 |
| [4] | Considered not related to CERE-120 |
| [5] | Considered not related to CERE-120, Related to surgical procedure |
| [6] | Neither death was considered related to CERE-120 |
Other Adverse Events
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications of Results:
| 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:
|
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
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 |