A Safety and Tolerability Study of ILB® in Patients With Amyotrophic Lateral Sclerosis (ALS) (NCT03705390) | Clinical Trial Compass
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 range18 Years
SexALL
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
✓. 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)
Exclusion criteria
✕. 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
✕
What they're measuring
1
Safety Assessed by SAEs and AEs - Measured by Incidence
Timeframe: From informed consent up to 30 days after last administration of trial treatment
2
Safety Assessed by AEs - Summarised by Grade
Timeframe: From informed consent up to 30 days after last administration of trial treatment
3
Safety Assessed by AEs - Summarised by Relatedness
Timeframe: From informed consent up to 30 days after last administration of trial treatment
4
Safety Assessed by SAEs - Summarised by Admitting Event Grade
Timeframe: From informed consent up to 30 days after last administration of trial treatment
5
Safety Assessed by SAEs - Summarised by Admitting Event Relatedness
Timeframe: From informed consent up to 30 days after last administration of trial treatment
6
Safety Assessed by SAEs - Summarised by Admitting Event Type
Timeframe: From informed consent up to 30 days after last administration of trial treatment
7
Safety Assessed by SAEs - Summarised by Expectedness
Timeframe: From informed consent up to 30 days after last administration of trial treatment
✕. 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
✕. 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)
8
Safety Assessed by SAEs - Summarised by Sequelae
Timeframe: From informed consent up to 30 days after last administration of trial treatment
9
Tolerability Assessed by the Incidence of Intolerable Adverse Events
Timeframe: From informed consent up to 30 days after last administration of trial treatment
10
Quantity of Study Drug Administered - Total Drug Administered
Timeframe: From baseline to final treatment visit
11
Quantity of Study Drug Administered - Number of Administrations
Timeframe: From baseline to final treatment visit
12
Quantity of Study Drug Administered - Number of Interruptions
Timeframe: From baseline to final treatment visit
13
Quantity of Study Drug Administered - Duration of Interruptions
Timeframe: From baseline to final treatment visit
14
Quantity of Study Drug Administered - Number of Discontinuations