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A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis

NCT00800501 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-12-06

No results posted yet for this study

Summary

This study is conducted to evaluate the safety and tolerability of the drug product sNN0029, containing the growth factor VEGF165, 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 Amyotrophic Lateral Sclerosis will be enrolled.

Conditions

Interventions

DRUG

sNN0029

Continuous ICV infusion at one of three dose levels

DRUG

Placebo

Continuous ICV infusion

Sponsors & Collaborators

  • Medtronic

    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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800501 on ClinicalTrials.gov