TRICALS:

A consortium that delivers

TRICALS provides access to internationally recognised leaders in the field of ALS who have the latest scientific knowledge of clinical trial design and methodology, outcome measures and statistical analysis.

Accelerate your research into a cure for ALS

Together with patients, patients’ organisations, and industry TRICALS wants to change the speed of development for novel effective treatments and include more ALS patients in clinical trials by:

  • Refining patient selection to increase patient enrolment;
  • Advancing trial methodology to maximize efficiency;
  • Overhauling clinical endpoints to optimize probability of success.

Our expertise and services

Population selection

Target the right patient at the right time

  • Access to large Pan-European population-based registries
  • Integrate genomic data to define responsive subgroups of patients (precision medicine)
  • Maximize recruitment and minimize disease heterogeneity with our predictive strategies
Outcome measures

Optimize success with the right endpoints

  • Develop personalized patient reported outcomes
  • Establish composite endpoints of daily functioning and survival
  • Use innovative biomarkers to monitor disease progression and to confirm target engagement
  • Minimize patient burden with cutting-edge digital health technologies
Trial design

Maximize efficiency with innovative trial design

  • Minimize sample size and trial duration with adaptive design
  • Event based trial design
  • Optional master protocol to use our platform trial
Patient recruitment

Increase recruitment with more patients in fewer sites

  • Excellent track record of patient recruitment (industry sponsored and investigator-initiated trials)
  • Use our outstanding network of large centres with trained and certified (mandatory) centres
  • Rapid site start-up due to Master contract
  • Low variability between sites due to high patient enrolment per site and training
Training

Optimize quality with dedicated and trained staff

  • TRICALS trial sites supported with targeted training
  • Dedicated research staff at TRICALS centres
  • Oversight by ‘TRICALS Clinical Trials Workgroup’
  • Established relationship with science focussed clinical CRO partner
Statistical analysis

Optimize statistical analysis plans

  • Statistical and design consultation services
  • Protocol drafting, review and feedback
  • CDISC data validation to ensure regulatory data submission requirements
  • Data analysis following acceptable industry data analysis standards
Patient involvement

Closer involvement of patients

  • Patient advisory board
  • Close collaboration with European patient organisation through EUPALS

Accomplishments & impact

TRICALS has an excellent track record in industry and investigator-initiated trials and in patient recruitment. Its network of large trained specialised ALS centres and the close involvement of patients and patient organisations is unique.

42

large specialised ALS centres

16

different countries

170

patients seen per site per year

3.500

new patients seen every year

320

dedicated research staff

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 to subgroups so that therapies can be developed to target individual subgroups, so we would have a superiour response going forward”

Principal researchers

Orla Hardiman

Professor of Neurology

Professor Orla Hardiman is Professor of Neurology, Consultant Neurologist at the National Neuroscience Centre, and Director of the National ALS Clinic & Irish ALS Research Group

Orla Hardiman
Current trials
Recruiting
Phase iii

TUDCA-ALS (TUDCA)

Industry sponsored trial

TUDCA (tauroursodeoxycholic acid) is a small molecule that is being explored for its potential as a treatment for ALS

Read more
In preparation
Phase iii

PreLude (Lithium carbonate)

Platform trial arm

Within an innovative platform design study, we will evaluate the efficacy of lithium carbonate in UNC13a homozygous patients.

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In preparation
Phase ii

Lighthouse (Triumeq)

Platform trial arm

Within an innovative platform design study, we will evaluate the efficacy of Triumeq, a therapy developed for treatment of HIV that has shown to slow progression in ALS

Read more
In preparation
Phase iii

iAdore (Oral edaravone)

Platform trial arm

Within an innovative platform design study, we will evaluate the efficacy of oral edaravone (TW001), a formulation that reduces oxidative stress

Read more
Want to accelerate your research?

Contact us to learn how TRICALS can collaborate with you to accelerate your research?