Status:
COMPLETED
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Lead Sponsor:
Newron Sweden AB
Collaborating Sponsors:
Medtronic
TFS Trial Form Support
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-75 years
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01807338
Start Date
August 1 2011
End Date
August 1 2014
Last Update
October 9 2014
Active Locations (1)
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1
Department of Neurology, Skåne University Hospital
Lund, Sweden, 221 85