NCT03705390

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

A Phase II Pilot Single-arm Safety and Tolerability Study of ILB® in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Amyotrophic Lateral Sclerosis (ALS) belongs to a wider group of disorders known as motor neuron diseases and mainly involves the nerve cells (neurons) in the body. Voluntary muscles produce movements like chewing, walking and talking. ALS is caused by gradual deterioration (degeneration) and death of these motor neurons. The disease is progressive, meaning the symptoms get worse over time and most people with ALS die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. Currently there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease (National Institute of Neurological Disorders and Stroke, Fact Sheet). The aim of this study is to explore the safety and acceptability of a type of low molecular weight dextran sulfate called ILB®. The investigators will invite 15 patients to take part from a single centre in the United Kingdom (UK). Participants will be closely monitored for any side-effects; for changes in ALS symptoms and on quality of life during and after the study. The trial period for patient participation is maximum 56 weeks (12 months), ILB® injections will be administered once weekly for up to a maximum of 48 weeks.

Conditions

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Interventions

Type	Name	Description
DRUG	ILB®	Administration will be weekly subcutaneous injections at a dose of 2mg/kg once per week for up to a maximum of 48 weeks

Timeline

• Start date: 2019-03-29
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2018-10-15
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

1 site across 1 country: United Kingdom