2024-513927-18-00RecruitingPhase 2
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Jun 2026
Brief summary (registry, in English)
To evaluate the efficacy of ILB® compared to Riluzole in reducing disease progression in participants with amyotrophic lateral sclerosis (ALS)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 16 Feb 2026
- Lead sponsor
- Oslo University Hospital HF
- Diseases
- ALS (motor neurone disease)
- EU CT number
- 2024-513927-18-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 116
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with ALS (amyotrophic lateral sclerosis) in stable health, whose symptoms began within the last 24 months and who already take riluzole.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- ALS diagnosed by the revised Gold Coast criteria. Symptoms began 24 months ago or less. Disease progression rate ∆FRS of 0.4 or more. FVC of 60 % or more of the predicted value. ALSFRS-R score of at least 28 points.
- Earlier treatment
- Must have started riluzole (100 mg/day) at least 2 weeks before screening and be willing to pause it 48 hours before Day 1. Cannot have taken warfarin or direct oral anticoagulants (DOACs) in the 14 days before screening.
Main reasons for not taking part
- Dementia, other brain or nerve diseases, or other serious uncontrolled disease that could affect the trial
- Pregnant or nursing
- Alcohol, drug or medication abuse in the 12 months before screening
- Known allergy to dextran sulfate, riluzole or other ingredients of the trial medicines
- Clinically significant abnormal blood clotting results at screening
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Participants receiving active treatment with drugs warfarin and direct oral anticoagulants (DOACs) 14 days prior to screening visit.
Other illness
- 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 with known allergy or intolerability to dextran sulfate, riluzole, and other ingredients of the IMPs.
Lab values
- 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
Other
- A participant who is pregnant or nursing.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helse Bergen HF | Bergen | Norway | Recruiting |
| Nordlandssykehuset HF | Bodo | Norway | Recruiting |
| Sykehuset Innlandet HF | Brumunddal | Norway | Recruiting |
| Vestre Viken HF | Drammen | Norway | Recruiting |
| Sykehuset Oestfold HF Kalnes | Graalum | Norway | Recruiting |
| Sorlandet Sykehus HF | Kristiansand S | Norway | Recruiting |
| Akershus University Hospital | Loerenskog | Norway | Recruiting |
| Helse Moere Og Romsdal HF | Molde | Norway | Recruiting |
| Oslo University Hospital HF | Oslo | Norway | Recruiting |
| Sykehuset Telemark HF | Skien | Norway | Recruiting |
| Helse Stavanger HF | Stavanger | Norway | Recruiting |
| Sykehuset I Vestfold HF | Toensberg | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF | Trondheim | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.