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A Safety Study of sNN0029 Administration Via Intracerebroventricular Route to Patients With ALS

NCT01999803 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-01-27

No results posted yet for this study

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).

Conditions

Interventions

DRUG

sNN0029

DRUG

Placebo

Sponsors & Collaborators

  • Newron Sweden AB

    lead INDUSTRY

Principal Investigators

  • Philip VanDamme, Prof, MD · University Hospital Leuven, Herestraat 49, B-3000 Leuven, Belgium

  • Leonard van den Berg, MD, Prof · University Medical Center Utrecht, Department of Neurology G03.228, P.O. Box 85500, NL-3508 GA Utrecht, The Netherlands

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
2014-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01999803 on ClinicalTrials.gov