A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807338
• Other study ID #: sNN0031-002
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: October 8, 2014
• Start date: August 2011
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Newron Sweden AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Sweden	Department of Neurology, Skåne University Hospital	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Newron Sweden AB	Medtronic, TFS Trial Form Support

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		up to 3 years	Yes