A Safety and Tolerability Study of ILB® in Patients With Amyotrophic Lateral Sclerosis (ALS)

Phase 2 Terminated 11 enrolled University of Birmingham Neuregenix Ltd · collab TikoMed AB · collab University Hospital Birmingham · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase II study to determine the safety and tolerability of ILB®, a type of low molecular weight dextran sulfate, in patients with Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)

Timeline

Start: 2019-03-29
Primary completion: 2021-07-28
Completion: 2021-07-28

Outcome

Outcome not reported

Stopped (Enrollment): “Study initially suspended due to COVID-19 Pandemic- treatment stopped - never reopened to recruitment..”

Publications

Srinivasan V, Homer V, Barton D, Clutterbuck-James A, Jenkins S, Potter C, Brock K, Logan A, Smith D, Bruce L, Nagy Z, Bach SP. A low molecular weight dextran sulphate, ILB(R), for the treatment of amyotrophic lateral sclerosis (ALS): An open-label, single-arm, single-centre, phase II trial. PLoS One. 2024 Jul 11;19(7):e0291285. doi: 10.1371/journal.pone.0291285. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ILB®	Other / unclassified	2 mg/kg	Subcutaneous