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

Newron

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01807338

sNN0031-002

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

saline

Description:

Saline administration to patients with idiopathic Parkinson's disease (PD) of moderate severity, who have previously been treated with sNN0031