Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT00866502
Status:
COMPLETED
Last Update Posted:
2015-01-12
First Post:
2009-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Sponsor:
Newron Sweden AB
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump.
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.
Detailed Description:
Tremor, rigidity, slow movement, poor balance, and difficulty walking are characteristic symptoms of Parkinson's disease (PD) that are associated with degeneration of dopamine-producing nerve cells in the brain. Administration of growth factors that stimulate neuronal stem and progenitor cells is one possible approach to restore the dopaminergic activity. The drug product sNN0031 containing the endogenous growth factor PDGF has been demonstrated to reduce the typical symptoms in animal models of PD.
NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in the form of the drug product sNN0031 can improve motor function in patients with PD. In this first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks follow-up will be evaluated.
NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in the form of the drug product sNN0031 can improve motor function in patients with PD. In this first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks follow-up will be evaluated.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Q-26239 | None | None | View |