Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:38 PM
Study NCT ID:
NCT01829867
Status:
TERMINATED
Last Update Posted:
2016-01-27
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.
Sponsor:
Newron Sweden AB
Organization:
Study Overview
Official Title:
A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 μg by Intracerebroventricular Infusion
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Issues with development and supply of infusion system for delivery of IMP. Prolonged approval process for the clinical study sNN0031-004.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of a dose of 95μg sNN0031 after intracerebroventricular administration to patients with Parkinson's disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: