Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-03-03 @ 2:22 AM
Study NCT ID:
NCT01999803
Status:
TERMINATED
Last Update Posted:
2016-01-27
First Post:
2013-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of sNN0029 Administration Via Intracerebroventricular Route to Patients With ALS
Sponsor:
Newron Sweden AB
Organization:
Study Overview
Official Title:
A Phase I, Randomised, Double-blind, Placebo-controlled Study in Patients With Amyotrophic Lateral Sclerosis to Further Assess the Safety and Tolerability of Intracerebroventricular Administration of sNN0029 Infusion Solution
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. Lack of favorable benefit risk ratio in sNN0029-003 study (review of interim data).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I, multicentre randomised, double-blind, placebo-controlled trial to assess the safety and tolerability of continuous i.c.v. administration of sNN0029 infusion solution at a dose of 4µg/day in patients with Amyotrophic Lateral Sclerosis (ALS).
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001026-10 | EUDRACT_NUMBER | None | View |