drugset / Trial / NCT01999803

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

NCT01999803 ↗

Phase 1 Terminated 15 enrolled Newron Sweden AB
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2014-09
Primary completion
2015-10
Completion
2015-10

Outcome

Outcome not reported

Stopped: “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).”

Drugs

EvaluationDrugModalityDoseRoute
Subject sNN0029 Unknown 4 ug Other