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A Phase 2, Randomized, Double-Blind, Double-Dummy Study Evaluating the Efficacy, Safety and Biomarkers Effect of ILB® versus Riluzole in participants with Amyotrophic Lateral Sclerosis
EU CTIS ID: 2024-513927-18-00
What this study is testing
To evaluate the efficacy of ILB® compared to Riluzole in reducing disease progression in participants with amyotrophic lateral sclerosis (ALS)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 to 80 years inclusive at the time of signing the informed consent.
- Must be in a stable health condition as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring at screening.
- Male or female diagnosed with ALS according to the World Federation of Neurology revised Gold Coast criteria
- Onset of ALS symptoms ≤ 24 months at screening visit.
- Disease progression rate ∆FRS ≥ 0.4 at screening.
- FVC ≥ 60 % (Forced Vital Capacity) of predicted valued for gender, height, and age at screening.
You likely can't join if
- A participant with dementia, other neurodegenerative diseases (e.g. Parkinson disease, multiple sclerosis) or any significant uncontrolled neurological, psychiatric, neoplastic, systemic, or organic disease (e.g. significant renal, hepatic or pulmonary disorder with on-going treatment not attributed to ALS) that, in the opinion of the investigator or medical monitor, could interfere with the conduct of the trial or affect its results.
- A participant who is pregnant or nursing.
- A participant with a history (within 12 months before screening) of current alcohol, drug, or medication abuse, as assessed by the investigator. Alcohol abuse is defined as consuming more than 14 units per week
- A participant with known allergy or intolerability to dextran sulfate, riluzole, and other ingredients of the IMPs.
- Participants receiving active treatment with drugs warfarin and direct oral anticoagulants (DOACs) 14 days prior to screening visit.
- A participant having clinically significant abnormal coagulation parameters: prothrombin complex-international normalized ratio (INR) > 1.5, fibrinogen <1.5 g/L, von Willebrand factor deficit and APTT > 41 seconds at screening
See the full eligibility criteria
- Age 18 to 80 years inclusive at the time of signing the informed consent.
- Must be in a stable health condition as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring at screening.
- Male or female diagnosed with ALS according to the World Federation of Neurology revised Gold Coast criteria
- Onset of ALS symptoms ≤ 24 months at screening visit.
- Disease progression rate ∆FRS ≥ 0.4 at screening.
- FVC ≥ 60 % (Forced Vital Capacity) of predicted valued for gender, height, and age at screening.
- Must have started treatment of Riluzole (100 mg/day) at least 2 weeks prior to screening and willing to pause Riluzole 48 hours prior to the baseline visit (Day 1).
- ALSFRS-R score of at least 28 points at screening.
- A participant with dementia, other neurodegenerative diseases (e.g. Parkinson disease, multiple sclerosis) or any significant uncontrolled neurological, psychiatric, neoplastic, systemic, or organic disease (e.g. significant renal, hepatic or pulmonary disorder with on-going treatment not attributed to ALS) that, in the opinion of the investigator or medical monitor, could interfere with the conduct of the trial or affect its results.
- A participant who is pregnant or nursing.
- A participant with a history (within 12 months before screening) of current alcohol, drug, or medication abuse, as assessed by the investigator. Alcohol abuse is defined as consuming more than 14 units per week
- A participant with known allergy or intolerability to dextran sulfate, riluzole, and other ingredients of the IMPs.
- Participants receiving active treatment with drugs warfarin and direct oral anticoagulants (DOACs) 14 days prior to screening visit.
- A participant having clinically significant abnormal coagulation parameters: prothrombin complex-international normalized ratio (INR) > 1.5, fibrinogen <1.5 g/L, von Willebrand factor deficit and APTT > 41 seconds at screening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.