Amyotrophic Lateral SclerosisPhase 2ALSNCT03705390
A Safety and Tolerability Study of ILB® in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing ILB® in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by University of Birmingham at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- What is being tested?
- ILB®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2019to 28 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- presence of Upper Motor Neuron (UMN) (increased tone, brisk reflexes) as well as Lower Motor Neuron (LMN) (weakness,
- wasting and fasciculation) signs in the bulbar region and at least two of the other spinal regions (cervical, thoracic or lumbosacral) or
- presence of UMN and LMN signs in all three spinal regions (cervical, thoracic or lumbosacral)
- Electrophysiological tests (Electromyography (EMG) / Nerve Conduction Study (NCS)) that supports the diagnosis of Motor Neurone Disease (MND) and to exclude mimic disorders
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- 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
- Patient willing and able to comply with schedule visits, treatment plan and other study procedures.
- Patients taking Riluzole must have discontinued treatment ≥28 days prior to study entry (and following consent to take part in the study)
- Women Of Child Bearing Potential (WOCBP) who agree to use highly effective means of contraception (as defined in the Heads of Medicines Agencies_Clinical Trials Facilitation Group (HMA_CTFG) guideline (see Appendix 8) and in combination with a barrier contraception method (condom, diaphragm or cap) for the entirety of the study
Who cannot join
- Patients classified as either probable or possible ALS according to El Escorial Criteria.
- Subjects in whom other causes of neuromuscular weakness have not been excluded
- Assisted ventilation of any type within 3 months before the screening visit or at screening
- Patients requiring Radiologically Inserted Gastrostomy (RIG) or Percutaneous Endoscopic Gastroscopy (PEG) feeding
- Involvement in any other interventional study involving use of another Investigational Medicinal Product (IMP) or biological product, within 3 months of screening
- Any use of antioxidants, edaravone, tirasemtiv or CK-2127107 within 1 month before the screening visit
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- Any botulinum toxin use within 3 months before the screening visit.
- Any form of stem cell or gene therapy for the treatment of amyotrophic lateral sclerosis (ALS)
- Neuroimaging of brain and cervical spine with Magnetic Resonance imaging (MRI) indicating compressive myelopathy as an alternate diagnosis
- Laboratory examinations including Acetylcholine receptor (AChR) antibodies and Muscle Specific Kinase (MuSK) antibodies to exclude Bulbar onset Myasthenia gravis from Bulbar onset Motor neuron disease as an alternate diagnosis and Antinuclear Antibodies (ANA), Anti-neutrophil cytoplasmic antibodies (ANCA), Extractable Nuclear Antigen (ENA) antibodies, Creatine Kinase (CK), electrophoresis and immunoglobulin indicating an alternate diagnosis for muscle disease like Myositis
- Abnormal liver function defined as Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >3 times upper limit of normal
- Any head trauma, intracranial or spinal surgery within 3 months of trial entry
- Patients who have had recurrent falls will be excluded to reduce the risk of intracerebral haemorrhage with this IMP
- Current use of an anticoagulant e.g Warfarin, Aspirin, Clopidogrel, any novel anticoagulants (NOAC)s or low molecular weight subcutaneous heparin
- Uncontrolled severe hypertension defined as systolic blood pressure (SBP) ≥ 220 mmHg or diastolic blood pressure (DBP) ≥120 mmHg
- Current or previous history of heparin-induced thrombocytopenia
- Active peptic ulcer disease
- Known hypersensitivity to sulphur
- Severe liver insufficiency
- Patients with evidence of major psychiatric illness, significant cognitive impairment or clinically evident dementia that may interfere with the patients' ability to comply with study procedures
- Pulmonary illness (e.g asthma or Chronic Obstructive Pulmonary Disease (COPD)) requiring regular treatment
- Patient judged to be actively suicidal by the investigator during 3 months before the screening visit
- Subjects with a diagnosis of another neurodegenerative disease (e.g. Parkinson's disease, Alzheimer's disease and Frontotemporal dementia)
- Pregnant and/or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
About this study
Official title: A Phase II Pilot Single-arm Safety and Tolerability Study of ILB® in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)
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)
Read the 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.
- Being tested
- ILB®
- Keywords
- ILB, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILB®Drug
Also called DSSS5, TM-500, TM-700, LMW-DS
Administration will be weekly subcutaneous injections at a dose of 2mg/kg once per week for up to a maximum of 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| ILB® Arm | Experimental | ILB® subcutaneous injection at a dose of 2mg/kg once per week for up to a maximum of 48 weeks Receives: Drug: ILB® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessed by SAEs and AEs - Measured by Incidence
Measured by the number of serious adverse events (SAEs) and adverse events (AEs) using CTCAE grading v4.0.
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by AEs - Summarised by Grade
Grade refers to the severity of the AE as follows:
Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 - Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by AEs - Summarised by Relatedness
Relatedness categories: 1 = unrelated, 2 = unlikely to be related, 3 = possibly related, 4 = probably related, 5 = definitely related
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by SAEs - Summarised by Admitting Event Grade
Grade refers to the severity of the admitting event as follows:
Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 - Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by SAEs - Summarised by Admitting Event Relatedness
Relatedness categories: 1 = unrelated, 2 = unlikely to be related, 3 = possibly related, 4 = probably related, 5 = definitely related
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by SAEs - Summarised by Admitting Event Type
Description of the main event type - primary cause of admission (body system, Adverse event term and grade)
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by SAEs - Summarised by Expectedness
Serious Adverse Events only will be defined as expected or unexpected based on information provided in the Quick Reference Document
Measured: From informed consent up to 30 days after last administration of trial treatment
Safety Assessed by SAEs - Summarised by Sequelae
Outcome of serious adverse events only: Resolved with sequelae or Resolved without sequelae
Measured: From informed consent up to 30 days after last administration of trial treatment
Tolerability Assessed by the Incidence of Intolerable Adverse Events
An intolerable adverse event will satisfy all of the following criteria:
- Associated with a serious adverse event or a drug discontinuation of greater than three weeks;
- Grade 3, 4 or 5 in severity according to CTCAE version 4;
- In the opinion of the Investigator is i) definitely related or ii) probably related or iii) possibly related to the study drug treatment.
Adverse events which are considered unrelated or probably not related will not be classed as intolerable events.
Measured: From informed consent up to 30 days after last administration of trial treatment
Quantity of Study Drug Administered - Total Drug Administered
Total drug administered over the study period (measured in milligrams)
Measured: From baseline to final treatment visit
Quantity of Study Drug Administered - Number of Administrations
Numerical count of the number of study drug injections given whilst on the trial
Measured: From baseline to final treatment visit
Quantity of Study Drug Administered - Number of Interruptions
Numerical count of the number of study drug injections missed whilst on the trial
Measured: From baseline to final treatment visit
Quantity of Study Drug Administered - Duration of Interruptions
Length of interruptions in weeks between study drug injections for those participants that experienced a treatment interruption whilst on the trial
Measured: From baseline to final treatment visit
Quantity of Study Drug Administered - Number of Discontinuations
numerical count of patients who have discontinued study drug treatment
Measured: From baseline to final treatment visit
Secondary outcomes (9)
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) Score Change
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R). This patient reported outcome measures the subjective well-being of patients. There are 5 scales which are calculated and scored: physical mobility, independence,eating and drinking, communication,emotional functioning. Each is scored between 0-100. An improved condition is represented by a decreasing sub-scale score. These sub scales are then averaged to make a summary index score. The range of the summary index is 0-100 and an improved condition is represented by decreasing summary index score. For each of the sub-scales and summary index. Interpretation is as follows: 0-19 Never or very rarely, 20-39 rarely experience problems, 40-59 sometimes experience problems,60-79 often experience, 80-100 problems (nearly) always or unable to do at all. The scale of the summary score is also 0-100 with analogous interpretation to the sub scales. An increase in score is a worse outcome.
Measured: From baseline to final treatment visit
Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) Score Change
Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 . A functional rating scale including assessments of communication, mobility, dressing and respiration. the total score range is 0-40. An improved condition is represented by decreasing sub-scale score. Interpretation is as follows: 0 being the best outcome and 40 being the worst. Minimum value is 0 and Maximum value is 40 per time-point / questionnaire completion
Measured: From baseline to final treatment visit
Urinary p75ECD Change
Urinary p75 extracellular domain (p75ECD) is a biological fluid-based biomarker of ALS disease progression
Measured: From baseline to final treatment visit
Pharmacokinetics (PK; Amount of Detectable Drug) of ILB® in Plasma Following Administration
This outcome measure quantifies the amount of drug detectable in the blood after administration over time
Measured: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; Tmax) Statistics of ILB® in Plasma Following Administration
Tmax (the time the peak concentration occurred) was calculated to characterise the kinetic profile of ILB® in plasma post-administration
Measured: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; Cmax) Statistics of ILB® in Plasma Following Administration
Cmax (peak concentration of ILB® in plasma post-administration) was calculated to characterise the kinetic profile of ILB® in plasma post-administration
Measured: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; AUC0-last) Statistics of ILB® in Plasma Following Administration
AUC0-last (area under the curve time 0 (time of administration) to the last value above the limit of quantification) was calculated to characterise the kinetic profile of ILB® in plasma post-administration
Measured: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; t1/2) Statistics of ILB® in Plasma Following Administration
t1/2 (terminal half-life of ILB® in plasma post-administration) was calculated to characterise the kinetic profile of ILB® in plasma post-administration
Measured: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
NfL in Plasma Change
Plasma neurofilament light chain (NfL) is a blood-based biomarker for neurodegeneration
Measured: from baseline to final treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start29 Mar 2019
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Why it stopped: Study initially suspended due to COVID-19 Pandemic- treatment stopped - never reopened to recruitment..
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- TikoMed AB, University Hospital Birmingham, Neuregenix Ltd
- Responsible party
- Sponsor
- Investigators
- Venkataramanan Srinivasan, MRCP, MRCP, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705390
- Sponsor's protocol ID
- RG_17-250
- Acronym
- ALS
- Status last verified
- Jul 2024
- First submitted
- 11 Sep 2018
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38990927
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Single-arm Safety and Tolerability Study of ILB® in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT03705390
- Acronym / sponsor ID
- ALS / RG_17-250
- Keywords
- ILB, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study initially suspended due to COVID-19 Pandemic- treatment stopped - never reopened to recruitment..
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- TikoMed AB, University Hospital Birmingham, Neuregenix Ltd
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILB® Arm | Experimental | Drug: ILB®ILB® subcutaneous injection at a dose of 2mg/kg once per week for up to a maximum of 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (24 listed)
- Patients classified as either probable or possible ALS according to El Escorial Criteria.
- Subjects in whom other causes of neuromuscular weakness have not been excluded
- Assisted ventilation of any type within 3 months before the screening visit or at screening
- Patients requiring Radiologically Inserted Gastrostomy (RIG) or Percutaneous Endoscopic Gastroscopy (PEG) feeding
- Involvement in any other interventional study involving use of another Investigational Medicinal Product (IMP) or biological product, within 3 months of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILB®Also: DSSS5, TM-500, TM-700, LMW-DSAdministration will be weekly subcutaneous injections at a dose of 2mg/kg once per week for up to a maximum of 48 weeks | Drug | ILB® Arm |
Primary outcome
Safety Assessed by SAEs and AEs - Measured by Incidence
Time frame: From informed consent up to 30 days after last administration of trial treatment
Measured by the number of serious adverse events (SAEs) and adverse events (AEs) using CTCAE grading v4.0.
Safety Assessed by AEs - Summarised by Grade
Time frame: From informed consent up to 30 days after last administration of trial treatment
Grade refers to the severity of the AE as follows: Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.
Safety Assessed by AEs - Summarised by Relatedness
Time frame: From informed consent up to 30 days after last administration of trial treatment
Relatedness categories: 1 = unrelated, 2 = unlikely to be related, 3 = possibly related, 4 = probably related, 5 = definitely related
Safety Assessed by SAEs - Summarised by Admitting Event Grade
Time frame: From informed consent up to 30 days after last administration of trial treatment
Grade refers to the severity of the admitting event as follows: Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.
Safety Assessed by SAEs - Summarised by Admitting Event Relatedness
Time frame: From informed consent up to 30 days after last administration of trial treatment
Relatedness categories: 1 = unrelated, 2 = unlikely to be related, 3 = possibly related, 4 = probably related, 5 = definitely related
Safety Assessed by SAEs - Summarised by Admitting Event Type
Time frame: From informed consent up to 30 days after last administration of trial treatment
Description of the main event type - primary cause of admission (body system, Adverse event term and grade)
Safety Assessed by SAEs - Summarised by Expectedness
Time frame: From informed consent up to 30 days after last administration of trial treatment
Serious Adverse Events only will be defined as expected or unexpected based on information provided in the Quick Reference Document
Safety Assessed by SAEs - Summarised by Sequelae
Time frame: From informed consent up to 30 days after last administration of trial treatment
Outcome of serious adverse events only: Resolved with sequelae or Resolved without sequelae
Tolerability Assessed by the Incidence of Intolerable Adverse Events
Time frame: From informed consent up to 30 days after last administration of trial treatment
An intolerable adverse event will satisfy all of the following criteria: 1. Associated with a serious adverse event or a drug discontinuation of greater than three weeks; 2. Grade 3, 4 or 5 in severity according to CTCAE version 4; 3. In the opinion of the Investigator is i) definitely related or ii) probably related or iii) possibly related to the study drug treatment. Adverse events which are considered unrelated or probably not related will not be classed as intolerable events.
Quantity of Study Drug Administered - Total Drug Administered
Time frame: From baseline to final treatment visit
Total drug administered over the study period (measured in milligrams)
Quantity of Study Drug Administered - Number of Administrations
Time frame: From baseline to final treatment visit
Numerical count of the number of study drug injections given whilst on the trial
Quantity of Study Drug Administered - Number of Interruptions
Time frame: From baseline to final treatment visit
Numerical count of the number of study drug injections missed whilst on the trial
Quantity of Study Drug Administered - Duration of Interruptions
Time frame: From baseline to final treatment visit
Length of interruptions in weeks between study drug injections for those participants that experienced a treatment interruption whilst on the trial
Quantity of Study Drug Administered - Number of Discontinuations
Time frame: From baseline to final treatment visit
numerical count of patients who have discontinued study drug treatment
9 secondary outcomes
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) Score Change
Time frame: From baseline to final treatment visit
Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) Score Change
Time frame: From baseline to final treatment visit
Urinary p75ECD Change
Time frame: From baseline to final treatment visit
Pharmacokinetics (PK; Amount of Detectable Drug) of ILB® in Plasma Following Administration
Time frame: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; Tmax) Statistics of ILB® in Plasma Following Administration
Time frame: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; Cmax) Statistics of ILB® in Plasma Following Administration
Time frame: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; AUC0-last) Statistics of ILB® in Plasma Following Administration
Time frame: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
Pharmacokinetics (PK; t1/2) Statistics of ILB® in Plasma Following Administration
Time frame: 0.5,1,2,2.5,3,4 and 6 hours post first ILB® administration
NfL in Plasma Change
Time frame: from baseline to final treatment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38990927Srinivasan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkataramanan Srinivasan, MRCP, MRCP principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ILB® in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessed by SAEs and AEs - Measured by Incidence (time frame: From informed consent up to 30 days after last administration of trial treatment). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.