TRICALS

A consortium that delivers

The TRICALS consortium internationally unites leading ALS-experts, patient advocacy groups and ALS foundations. By working together, we can accelerate clinical drug development for ALS.

Transform your compound into a cure for ALS together with TRICALS

Through our unique network of harmonised and trial-ready ALS centres, we serve  a well-defined patient population across 15 countries. All our centres are large and specialised, with an excellent track record in industry and investigator-initiated clinical trials, which deliver rapid and on target participant recruitment and high-quality outcome data. 

TRICALS can support pharmaceutical and biotech companies in their clinical trials research with our trial-ready infrastructure and leading experts, allowing for an effective study design, harmonised outcome measures and high patient recruitment. Only by working together, can we advance effective treatments for people living with ALS. 

Our services and scientific expertise

Trial conduct

Accelerate phase I-III trials with our infrastructure

  • Project and site management
  • (Pre)feasibility and site selection
  • Patient recruitment and retention
  • Centralised patient database
  • Central lab (genetics & advanced biomarkers)
  • CRO collaboration 
  • Specialised Data Safety Monitoring Board
Training

Optimise quality with dedicated and trained staff

  • Experienced trainers
  • Training on outcome measures ALSFRS-R, Staging, HHD, ECAS, Respiratory function, MUNIX
  • All staff at TRICALS sites certified and regularly trained in ALS outcome measures
Master protocol

Avoid reinventing the wheel

  • Master protocol including innovations (such as eligibility criteria and endpoints)
  • Option of utilising the MAGNET platform trial or a standalone trial
Patient involvement

Closer involvement of patients

  • International patient advisory board informing trial design
  • Close collaboration with EUPALS and national patient organisations
  • Engaged patients through TRICALS patient registry
Scientific expertise

Leading the way in trial design

  • Full methodological and statistical support
  • Targeted and increased inclusion with a validated survival prediction model
  • Personalised patient reported outcomes
  • Improved composite endpoints
  • Innovative biomarkers 
  • Cutting-edge digital health technology
  • Adaptive and event based trial design

Our mission is simple: make ALS clinical trials more efficient

Noel - patient

TRICALS will further the efficacy of therapies

“I hope that with TRICALS we can develop the ability to segment ALS so that therapies can be developed to target individual subgroups”

Access our growing network of ALS experts

Orla Hardiman

Professor of Neurology

Professor Hardiman trained in Neurology in Boston prior to her appointment as […]

Orla Hardiman
Current trials
Recruiting
Phase ii

DAZALS trial

Industry trial
In this study, an investigational oral drug named dazucorilant (also called CORT113176) is being studied in people living with ALS (also known as MND) to understand its safety (side effects) and to determine if dazucorilant can slow down the worsening of the disease. The effects of dazucorilant will be compared to the effects of a placebo. This study is sponsored by Corcept Therapeutics.
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Recruiting
Phase ii

CARDINALS

Industry trial
The CARDINALS clinical research study is evaluating a study drug (Utreloxastat) to see if it can help slow ALS symptoms. Researchers will also test the safety and tolerability of the study drug and how the body responds to it. The study drug is a liquid that is swallowed 2 times a day.
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Recruiting
Phase ii

AP101-02

Gesponsorde Trial
In this study we investigate the safety, tolerability, pharmacodynamics markers and pharmacokinetics (how a drug is absorbed and excreted) of AP-101 in patients with familial and sporadic amyotrophic lateral sclerosis (ALS). Currently, we are only looking for patients with familial ALS (caused by a SOD1 gene mutation) to participate in the study. This study is sponsored by AL-S Pharma.
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Recruiting
Phase iii

ATLAS trial

Industry trial
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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Recruiting
Phase iii

FUSION trial

Industry trial
In this study we investigate the safety and efficacy of the study drug ‘ION363’ for the treatment of ALS caused by mutations in the FUS gene. About 1% to 5% of ALS cases are caused by FUS mutations.
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Active
Phase iii

PHOENIX trial

Industry trial
Amylyx Pharmaceuticals Inc is conducting a phase 3 trial to determine the safety and efficacy of their compound 'AMX0035' for the treatment of ALS.
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Completed
Phase iii

ADORE trial

Industry trial
Ferrer is conducting a phase 3 trial to evaluate the safety and potential efficacy of an investigational drug for people with Amyotrophic Lateral Sclerosis (ALS).
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Active
Phase iii

TUDCA-ALS

Investigator initiated trial
This trial will evaluate the efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment for people with ALS.
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Contact us

Contact us to learn how TRICALS can collaborate with you to transform your compound into a cure