Back to resultsA Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Locations
Sweden
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001
- The patient has a diagnosis of idiopathic PD
- The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
- The patient has provided written informed consent to participate in the follow-up study
Exclusion Criteria:
- The patient has been included or participates in another clinical study after participation in Study sNN0031-001
- The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation).
- Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study
Sites / Locations
- Department of Neurology, Skåne University Hospital
Arms of the Study
Arm 1
Arm Type
Arm Label
saline
Arm Description
Saline administration to patients with idiopathic Parkinson's disease (PD) of moderate severity, who have previously been treated with sNN0031
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT01807338
First Posted
March 7, 2013
Last Updated
October 8, 2014
Sponsor
Newron Sweden AB
Collaborators
Medtronic, TFS Trial Form Support
1. Study Identification
Unique Protocol Identification Number
NCT01807338
Brief Title
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Official Title
A Follow-up Study on Safety and Tolerability and Pharmacodynamic Effect, of Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Who Have Previously Been Treated With sNN0031, Using an Implanted Catheter and a SynchroMed® II Pump
Study Type
Observational
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newron Sweden AB
Collaborators
Medtronic, TFS Trial Form Support
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
saline
Arm Description
Saline administration to patients with idiopathic Parkinson's disease (PD) of moderate severity, who have previously been treated with sNN0031
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001
The patient has a diagnosis of idiopathic PD
The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
The patient has provided written informed consent to participate in the follow-up study
Exclusion Criteria:
The patient has been included or participates in another clinical study after participation in Study sNN0031-001
The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation).
Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study
Study Population Description
Patients diagnosed with idiopathic PD of moderate severity who have completed participation in study sNN0031-001.
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Department of Neurology, Skåne University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
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