A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT01807338
- Lead Sponsor
- Newron Sweden AB
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events up to 3 years
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the long-term molecular effects of PDGF-BB on dopaminergic neurons in Parkinson's Disease patients post-ICV administration?
How does intracerebroventricular delivery of PDGF-BB compare to standard-of-care therapies for moderate idiopathic Parkinson's Disease in terms of efficacy and safety?
Which biomarkers correlate with improved motor function following PDGF-BB treatment in Parkinson's Disease clinical trials?
What adverse events are associated with SynchroMed® II pump-based ICV PDGF-BB administration in Parkinson's Disease and how are they managed?
Are there combination therapies involving PDGF-BB and MAO-B inhibitors that enhance neuroprotection in Parkinson's Disease?
Trial Locations
- Locations (1)
Department of Neurology, Skåne University Hospital
🇸🇪Lund, Sweden
Department of Neurology, Skåne University Hospital🇸🇪Lund, Sweden