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
Key facts
- Where
- Bergen, Bodo, Brumunddal, Drammen, Graalum, Kristiansand S, Loerenskog, Molde, Oslo, Skien, Stavanger, Toensberg, Tromsoe és Trondheim, NorvégiaSee the 14 sites
- Phase
- 2. fázis
Where in Norvégia
- Helse Bergen HFBergen, NorvégiaTaking people
- Nordlandssykehuset HFBodo, NorvégiaTaking people
- Sykehuset Innlandet HFBrumunddal, NorvégiaTaking people
- Vestre Viken HFDrammen, NorvégiaTaking people
- Sykehuset Oestfold HF KalnesGraalum, NorvégiaTaking people
- Sorlandet Sykehus HFKristiansand S, NorvégiaTaking people
- Akershus University HospitalLoerenskog, NorvégiaTaking people
- Helse Moere Og Romsdal HFMolde, NorvégiaTaking people
- Oslo University Hospital HFOslo, NorvégiaTaking people
- Sykehuset Telemark HFSkien, NorvégiaTaking people
- Helse Stavanger HFStavanger, NorvégiaTaking people
- Sykehuset I Vestfold HFToensberg, NorvégiaTaking people
- Universitetssykehuset Nord-Norge HFTromsoe, NorvégiaTaking people
- St. Olavs hospital HFTrondheim, NorvégiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- EU 2024-513927-18-00
- Record updated
- 2026. június 24.
- Original description
To evaluate the efficacy of ILB® compared to Riluzole in reducing disease progression in participants with amyotrophic lateral sclerosis (ALS)Read full original descriptionShow less
To evaluate the efficacy of ILB® compared to Riluzole in reducing disease progression in participants with amyotrophic lateral sclerosis (ALS)
Inclusion: 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.
Exclusion: 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; 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; 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; A participant who is pregnant or nursing.