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Neurodevelopmental Disorders Clinical Trials Centre (NDD-CTC)

Aims

We undertake clinical trials for the core symptoms and associated conditions of neurodevelopmental disorders in collaboration with industry partners, King’s clinical trials unitKHP clinical trials office, the NIHR Maudsley Biomedical Research Centre and the NIHR / Wellcome Trust King's Clinical Research Facility. 

 

Our focus

The NDD-CTC undertakes fully powered clinical trials of potential treatments identified in our clinical trials pipeline based on shiftability and other experimental studies within the department, and includes treatments for individuals with Autism spectrum conditions, Down syndrome, and intellectual disabilities.

 

Our Process

NDD-CTC Process
biomarkers1

 

Step 1:

Find biomarker of neurodevelopmental disorder or comorbid condition shared by a group of people

Shiftability2

 

Step 2:

Conduct 'shiftability study': target biomarker with dose of compound to test for response on biomarker

Biological1

 

Step 3:

Does this make a biological difference? NO - STOP

Pills_Fastfail1

Step 4:

Yes - move forward to 'Fast Fail' trial

Brain_fastfail1


Step 5:

Conduct 'Fast Fail' trial to test if we can maintain shift in the biomarker for ~weeks
NO - STOP

Pill Crop2


Step 6:

Yes - full clinical trial should be done in people we know should respond

Participants1

 

Step 7:
NDD-CTC conducts Phase II and III trials with ~hunderds of participant

Trials

V1ADUCT (NCT03504917; Sponsor – Hoffmann-La Roche)

This trial is to test Balovaptan for social function in adults (18 years and older) with Autism. National coordinator (UK) – Professor Murphy; Local PI – Professor Andre Strydom; sub-investigators Dr Rejaul Islam and Dr Beata Kowalewska.

    STAR-AIMS (NCT03682978)

    This trial will test if Arbaclofen will help to improve social function in children and young people (ages 5-17) with autism. This trial is part of the AIMS-2-TRIALS project. National Co-ordinator – Professor Andre Strydom; Investigators – Professor Tony Charman, Dr Eileen Daley, Dr Anya Kaushik.

      Trials

      V1ADUCT (NCT03504917; Sponsor – Hoffmann-La Roche)

      This trial is to test Balovaptan for social function in adults (18 years and older) with Autism. National coordinator (UK) – Professor Murphy; Local PI – Professor Andre Strydom; sub-investigators Dr Rejaul Islam and Dr Beata Kowalewska.

        STAR-AIMS (NCT03682978)

        This trial will test if Arbaclofen will help to improve social function in children and young people (ages 5-17) with autism. This trial is part of the AIMS-2-TRIALS project. National Co-ordinator – Professor Andre Strydom; Investigators – Professor Tony Charman, Dr Eileen Daley, Dr Anya Kaushik.

          Our Partners

          NIHR Maudsley Biomedical Research Centre (BRC) logo

          NIHR Maudsley Biomedical Research Centre

          Project status: Ongoing