An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis
NCT01384162 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2016-01-27
Summary
This is an open label safety and tolerability continuation study of intracerebroventricular administration of sNN0029, containing the growth factor VEGF165, in patients with amyotrophic lateral sclerosis that have previously participated in study sNN0029-001. The intention of the study is to investigate safety and tolerability of intracerebroventricular administration of sNN0029 and whether it can improve motor function and prolong survival in patients with ALS.
Conditions
Interventions
- DRUG
-
sNN0029
ICV infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
ICON Clinical Research
collaborator INDUSTRY -
Newron Sweden AB
lead INDUSTRY
Principal Investigators
-
Wim Robberecht, MD, PhD · University Hospital Leuven, Department of Neurology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2015-10-31
- Completion
- 2015-10-31
Countries
- Belgium
Study Locations
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