TerminatedPhase 2

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

Stopped: Study initially suspended due to COVID-19 Pandemic- treatment stopped - never reopened to recruitment..

United Kingdom11 participantsStarted 2019-03-29

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients ≥18 years and who have provided written informed consent to participate in the study
. Prior to trial entry patients will have a definite diagnosis of ALS according to El Escorial Criteria. All patients will demonstrate either:
. Electrophysiological tests (Electromyography (EMG) / Nerve Conduction Study (NCS)) that supports the diagnosis of Motor Neurone Disease (MND) and to exclude mimic disorders
. Forced Vital Capacity (FVC) ≥50% of predicted value for gender, height and age at screening and a mean Sniff Nasal Inspiratory Pressure (SNIP) ≥50% of predicted value for age
. Adequate haematological function (Hb≥10g/dl absolute neutrophil count ≥1.5x109/L and a platelet count ≥60 x109/L
. International Normalised Ratio (INR) ≤ 1.5, Activated Partial Thromboplastin Time (aPTT) 30 - 40 seconds, Prothrombin Time (PT) 11-13.5 seconds

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Assessed by SAEs and AEs - Measured by Incidence

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by AEs - Summarised by Grade

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by AEs - Summarised by Relatedness

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by SAEs - Summarised by Admitting Event Grade

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by SAEs - Summarised by Admitting Event Relatedness

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by SAEs - Summarised by Admitting Event Type

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Trial details

NCT IDNCT03705390

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-28

Results submitted2024-07-30

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients ≥18 years and who have provided written informed consent to participate in the study
. Prior to trial entry patients will have a definite diagnosis of ALS according to El Escorial Criteria. All patients will demonstrate either:
. Electrophysiological tests (Electromyography (EMG) / Nerve Conduction Study (NCS)) that supports the diagnosis of Motor Neurone Disease (MND) and to exclude mimic disorders
. Forced Vital Capacity (FVC) ≥50% of predicted value for gender, height and age at screening and a mean Sniff Nasal Inspiratory Pressure (SNIP) ≥50% of predicted value for age
. Adequate haematological function (Hb≥10g/dl absolute neutrophil count ≥1.5x109/L and a platelet count ≥60 x109/L
. International Normalised Ratio (INR) ≤ 1.5, Activated Partial Thromboplastin Time (aPTT) 30 - 40 seconds, Prothrombin Time (PT) 11-13.5 seconds

What they're measuring

Safety Assessed by SAEs and AEs - Measured by Incidence

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by AEs - Summarised by Grade

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by AEs - Summarised by Relatedness

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by SAEs - Summarised by Admitting Event Grade

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by SAEs - Summarised by Admitting Event Relatedness

Timeframe: From informed consent up to 30 days after last administration of trial treatment

Safety Assessed by SAEs - Summarised by Admitting Event Type

Timeframe: From informed consent up to 30 days after last administration of trial treatment

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria