CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Tocilizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02469896
NCT02469896Phase 2Completed
CompareCT.gov

A Phase 2 Randomized, Placebo Controlled Trial of Tocilizumab in ALS Subjects

Barrow Neurological Institute·interventional·Posted Jun 12, 2015·Updated Dec 18, 2019

In Brief

A Phase 2 clinical trial evaluating Tocilizumab and Placebo for ALS and 3 related conditions. Completed, enrolled 22 participants across 5 sites.

Detailed Summary

This research study is being done to find out if tocilizumab, also known as Actemra™, can help with Amyotrophic Lateral Sclerosis (ALS). The investigators also want to find out if tocilizumab is safe to take without causing too many side effects. Currently ALS has no cure and 2 modestly effective treatment to slow the progression of the disease. Although not the initial cause of ALS, the immune system plays a role in the death of motor neurons. The immune cells that participate in this process are stimulated by a substance called interleukin-6 (IL-6) whose effect is blocked by tocilizumab and thus, may slow the death of motor neurons and slow the disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALS, Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease, Motor Neuron Disease
CountriesUnited States
CollaboratorsALS Association, Barrow Neurological Foundation, Massachusetts General Hospital, Genentech, Inc.

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 12, 2015
Enrollment StartNov 1, 2015
Primary CompletionJul 11, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.1 years ago

Interventions

Tocilizumabdrug

IV Infusion

Placeboother

IV Infusion