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The European Medicines Agency (EMA) endorses TRICALS’ innovative platform trial

TRICALS has received the exciting news that the European Medicines Agency (EMA) endorses our plans for an innovative platform trial. Clinical trials investigating candidate medicines for ALS are costly, lengthy and often inaccessible for the majority of patients. This complicates and delays our search for effective ...

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Current developments in clinical trial design and conduct

Over 70 compounds have been evaluated by clinical studies, yet Riluzole is the only available treatment for people with ALS in Europe. The reasons for this unsuccessful road of drug development are many, including flawed clinical trial design, poor bench-to-bedside translation and the need for more robust biomarkers...

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Apellis reports discontinuation of MERIDIAN study

Pharmaceutical company Apellis has announced the discontinuation of the open-label phase of the MERIDIAN study (also called APL2-ALS-206 study). This decision was taken after review of the data by the data monitoring committee and the company’s medical team, which determined that the drug does not offer benefits for...

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Recording of virtual meeting: Adherence and retention in ALS clinical trials

On March 22, 2023, TRICALS organised its first virtual meeting: ‘Adherence and retention in ALS clinical trials – H ow to move beyond the state-of-the-art’. The meeting brought together leading experts in the field of ALS research, along with study staff, representatives from pharmaceutical compani...

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CENTAUR phase 2 trial reveals promising results

New findings from the CENTAUR trial show that the drug ‘sodium phenylbutyrate–taurursodiol’ (AMX0035) may slow down functional decline in persons living with ALS. The latest results of this multicentre, phase 2 trial were published on September 3rd in the renowned New England Journal of Medicine. These findings are ...

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COURAGE-ALS trial discontinued due to disappointing results

The company Cytokinetics has announced early termination of the COURAGE-ALS study. An interim analysis of the results found no evidence of the drug’s effectiveness. No difference in disease progression was observed between participants who received the study drug and participants who received the placebo (fake drug)...

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The ATLAS study - A clinical trial for people who want to contribute to SOD1-ALS research

Biogen is conducting a clinical trial to evaluate the efficacy and safety and of an investigational drug for adults who do not have any clinical signs or symptoms of Amyotrophic Lateral Sclerosis (ALS) that definitely indicate the onset of ALS, but do carry a certain superoxide dismutase 1 (SOD1) gene variant.

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Swimming the Catalan coast to raise funds for ALS research

To raise funds for TRICALS, Daniel Rossinés has taken on an epic challenge. In 24 consecutive days he is swimming the entire Catalan coast: 400 km. He started in Portbou (Girona) on the 17th of September and will finish in Les Cases d’Alcanar (Tarragona).

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Food and Drug Administration (FDA) approves AMX0035 (Amylyx) for the American market

During a meeting of the FDA’S Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) on Thursday September 29 2022, the Amylyx drug AMX0035 received approval under the name RELYVRIO (AMX0035). This means that Relyvrio is available for American citizens. What does this approval mean and how does thi...

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Measuring treatment effects based on patient preference

To evaluate the effect of an investigational drug in ALS clinical trials, we use measuring scales such as the ALSFRS-R or readouts of muscle strength. This is to objectively determine whether a drug can slow disease progression. However, this strategy may not consider the concerns most important to people living wit...

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The VALOR Study: A Clinical Trial for People Living with SOD1-ALS

Biogen is conducting a clinical trial to evaluate the safety and potential efficacy of an investigational drug for people with Amyotrophic Lateral Sclerosis (ALS) carrying a SOD1 gene mutation.

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TRICALS Enrols First Participants in Phase 3 MAGNET platform trial for ALS

TRICALS (the Treatment Research Initiative to Cure ALS), in collaboration with ALS associations and funding agencies from Europe and Australia, has launched its clinical platform trial for amyotrophic lateral sclerosis (ALS). The MAGNET (Multi-arm, Adaptive, Group-sequential trial NETwork) trial is an innovative cli...