Clinical Trials

The ScotCRN provides expert support for both medicinal (CTIMP) and non-medicinal (Non-CTIMP)trials.

Please use the tabs below to access information about medicinal and non-medicinal studies currently being supported by the ScotCRN.

ScotCRN Active Medicinal Trials 2014-15


ACCOUSTICS
A phase III, randomized, double–blind, placebo-controlled study to assess the efficacy, safety, and tolerability of Lebrikizumab in adolescent patients with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication.
Specialty:. Respiratory
Node: Glasgow PI: James Paton

ADALUMIBAB
A randomised double blind placebo controlled study of the human anti-TNF monuclonal antibody adalumibab in paediatric ubjects with moderate to severe ulcerative colitis
Specialty:. Gastroenterology
Node: Glasgow PI: Richard Russel

ADHD Genetics
How do polymorphisms in the CES1 study affect how children with ADHD respond to Methylphenidate?
Specialty:. Psychiatry
Node: Dundee PI: David Coghill

ALX-0171
Study of the effects of inhaled ALX-0171 in infants and toddlers with syncytial virus lower respiratory tract infection.
Specialty:. Genetics/Metabolic
Node: Edinburgh PI: Steve Cunningham

ALXN1101
ALXN1101 in paediatric patients with MoCD Type A treated with rcPMP.
Specialty:. Genetics/Metabolic
Node: Glasgow PI: Bernd Schwahn

APPLES Astellas Pharma Europe
Study to assess long term safety of Tacrolimus ointment for treatment of atopic dermatitis.
Specialty:. Dermatology
Node: Dundee PI: Ross Hearn
Node: PI:

DRAVET (Part A)
A double-blind, placebo-controlled, two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet Syndrome Dose finding arm of study.
Specialty:. Neurology
Node: Edinburgh PI:
Node: Glasgow PI: Sameer Zuberi

30 March 2015 Page 1 of 4

DRAVET (Part B)
A double-blind, placebo-controlled, two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet Syndrome
Specialty:. Neurology
Node: Glasgow PI: Sameer Zuberi

DRI
A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisabililty.
Specialty:. Neurology
Node: Edinburgh PI: Anne O’Hare

ESES
Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
Specialty:. Neurology
Node: Glasgow PI:
Node: Edinburgh PI: Richard Chin

Evicel
A Prospective Randomized Controlled Study Evaluating the Safety and Efficacy of EVICEL® used for SutureLine Sealing in DuraMater Closure during Paediatric Neurosurgical Cranial Procedures
Specialty:. Surgery
Node: Edinburgh PI: Jothy Kandasamay

FOR-DMD
Duchenne Muscular Dystrophy: Double blind randomised trial to find optimum steroid regimen
Specialty:. Genetics
Node: Glasgow PI: Ian Horrocks

ICISS
International, multi centre, randomised parallel group, trial investigating the medical treatment of infantile spasms.
Specialty:. Neurology
Node: Dundee PI: Martin Kirkpatrick
Node: Aberdeen PI: Ayaz Shah
Node: Edinburgh PI: Alisa McLellan

KLIMB
A Phase 3, 2-arm, roll-over study to evaluate the long-term safety and pharmacodynamics of Ivacaftor treatment in paediatric subjects With CF and a CFTR gating mutation.
Specialty:. Respiratory
Node: Edinburgh PI: Jane Davis

30 March 2015 Page 2 of 4

OAB
BOTOX in the treatment of urinary Incontinence in patients 12-17 Years of age
Specialty:. Urology
Node: Aberdeen PI: Christopher Driver

Phase 1 study in children with RSV
A randomized, double-blind, placebo-controlled, 2-part study of orally administered ALS-008176.
Specialty:. Respiratory
Node: Edinburgh PI: Steve Cunningham

PREDNOS
Long-term tapering versus standard prednisolone (steroid) therapy for the treatment of the initial episode of childhood nephrotic syndrome: national muliticentre randomised double blind trial.
Specialty:. Nephrology
Node: Edinburgh PI:
Node: Ayrshire and Arran PI: Bridget Oates
Node: Glasgow PI:
Node: Aberdeen PI: Craig Oxley

PREDNOS 2
Short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome.
Specialty:. Nephrology
Node: Aberdeen PI:
Node: Ayrshire and Arran PI:
Node: Glasgow PI: Heather Maxwell
Node: Edinburgh PI: David Hughes

SANAD II
A study of standard and new anti-epileptic drugs.
Specialty:. Neurology
Node: Edinburgh PI:
Node: Dundee PI: Martin Kirkpatrick

SNIFFLE 2
Safety of Nasal Influenza Immunisation in Egg Allergic Children
Specialty:. Immunology, allergy,
Node: Edinburgh PI: Jurgen Schwarze

SYCAMORE
Randomised controlled trial of the effectiveness, safety, and cost effectiveness of adalimumab in combination with subcutaneous methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis.
Specialty:. Rheumatology
Node: Edinburgh PI: Brian Fleck
Node: Aberdeen PI: Joyce Davidson
Node: Glasgow PI: Janet Gardner-Medwin

TORPEDO-CF
Trial of optimal therapy for pseudomonas eradication in CF.
Specialty:. Respiratory
Node: Edinburgh PI: Steve Cunningham

Vertex 2 (KONTINUE)
A phase 3, 2-arm, roll-over study to evaluate the long-term safety and pharmacodynamics of Ivacaftor treatment in paediatric subjects With CF and a CFTR gating mutation.
Specialty:. Respiratory
Node: Edinburgh PI: Steve Cunningham

VOCALS
The effect of lebrikizumab in patients with severe asthma
Specialty:. Respiratory
Node: Glasgow PI: James Paton


ScotCRN Active Non Medicinal Trials 2014-15


ADDUCE
ADHD drugs use chronic effects observational open label pharmacovigilance study.
Specialty: Psychiatry
Node: Dundee PI: David Coghill
Node: Edinburgh PI:

ADDUCE BP
Cross-sectional study of 24-hours blood pressure measures and left ventricular mass using echocardiograms in late adolescents and adults with ADHD.
Specialty: Psychiatry
Node: Dundee PI: David Coghill

BASICS
The British antibiotic and silver impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial.
Specialty: Surgery
Node: Edinburgh PI: Jothy Kandasamay

BCRD (Biologics)
The long term safety and efficacy of biologic therapies in children with rheumatic diseases.
Specialty: Rheumatology
Node: Ayrshire and Arran PI:
Node: Edinburgh PI: Jo Walsh
Node: Glasgow PI: Jo Walsh
Node: Dundee PI: Peter Fowlie
Node: Aberdeen PI:

BEST
Evaluation of the New Orleans model for infant mental health in Glasgow
Specialty: Development
Node: Glasgow PI: Helen Minnis

BIG Study
Gut microbial taxonomy and metabolism in paediatric Crohn’s disease during exclusive and supplementary enteral nutrition using OMICS technologies.
Specialty: Gastroenterology
Node: Glasgow PI: Richard Russell
Node: Ayrshire and Arran PI:

BSPAR
British Society for Paediatric and Adolescent Rheumatology Etanercept cohort study.
Specialty: Rheumatology
Node: Glasgow PI: Jo Walsh
Node: Dundee PI:

CAPS
Childhood arthritis prospective study.
Specialty: Rheumatology
Node: Glasgow PI: Joyce Davidson

30 March 2015 Page 1 of 6
Node: Edinburgh PI: Joyce Davidson

ChILD
Orphans Unite: chILD better together - European management platform for childhood nterstitial lung diseases: ChILD-EU database and observational study.
Specialty: Respiratory
Node: Glasgow PI: Neil Gibson
Node: Edinburgh PI: Steve Cunningham
Node: Aberdeen PI: Steve Turner
Node: Ayrshire and Arran PI:

Cleft Collective
The Cleft Collective Cohort studies
Specialty: Surgery
Node: Edinburgh PI: Felicity Mehendale

CORD
Immediate cord clamping with neonatal care at the roomside, versus deferred cord clamping with neonatal care at the bedside for preterm birth before 32 weeks gestation: a pilot randomised trial
Specialty: Neonatal
Node: Aberdeen PI: Medhat Ezzat

DDD
Deciphering developmental disorders.
Specialty: Development
Node: Dundee PI:

Dendritic RSV
Pro-inflammatory lung dendritic cells in stratified severe RSV bronchiolitis.
Specialty: Respiratory
Node: Edinburgh PI: Jurgen Schwarze
Node: Glasgow PI:

easypodConnect Registry
A Multi-centre, observational registry to study adherence and long term outcomes of therapy in paediatric participants using “easypod” electromechanical device for growth hormone treatment
Specialty: Diabetes
Node: Dundee PI: Stephen Greene

Eczema
Identification of major susceptibility genes for eczema and food allergy.
Specialty: Dermatology
Node: Edinburgh PI: Olivia Schofield
Node: Dundee PI: Sara Brown
Node: Glasgow PI: Paula Beattie

Enpyema (UK ESPA)
The national programme for enhanced pneumococcal surveillance of complicated pneumococcal pneumonia and empyema in UK children
Specialty: Respiratory
Node: Glasgow PI: James Paton

30 March 2015 Page 2 of 6

GACE
Genetic and autoimmune childhood epilepsy study.
Specialty: Neurology
Node: Aberdeen PI:
Node: Ayrshire and Arran PI:
Node: Edinburgh PI:
Node: Dundee PI:
Node: Glasgow PI: Sameer Zuberi

GEM
A Multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease
Specialty: Gastroenterology
Node: Glasgow PI: David Wilson
Node: Dundee PI: David Wilson
Node: Aberdeen PI: David Wilson
Node: Edinburgh PI: David Wilson

Genetics of otitis media study
The association of chronic otitis media with effusion (COME) and recurrent acute otitis media (RAOM) in UK hospital populations with the gentic loci Fbxo11 and Evi1.
Specialty: ENT
Node: Ayrshire and Arran PI: Mary Shanks
Node: Aberdeen PI: Derek Veitch
Node: Glasgow PI: Haytham Kubba

HAPPY Study
Hormone and Inflammation in pregnancy. Parents and Young Follow Up
Specialty: Neonatal
Node: Edinburgh PI: Mandy Drake

HCV UK
Host and viral factors associated with outcomes of infection with Hepatitis C virus.
Specialty: Immunology, allergy,
Node: Dundee PI: Sabarinathan Loganathan

HOT-KID study
A randomised trial to compare effects of aggressive versus standard targets in blood pressure on target organ damage in children with CKD.
Specialty: Nephrology
Node: Glasgow PI: Heather Maxwell

Image Kids
The ImageKids study: Developing the Pediatric Crohn’s Disease Intestinal Damage Score (PECDID score)
Specialty: Gastroenterology
Node: Glasgow PI: Richard Russell

INDIGO 2
Improving glucose variability in type 1 diabetes and its effect on the underlying homeostatic metabolic pathways of angiogenesis.
Specialty: Diabetes
Node: Dundee PI: Stephen Greene

JDCBS
Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland) for Idiopathic Inflammatory Myopathies.
Specialty: Dermatology
Node: Aberdeen PI: Joyce Davidson

JIA Genetics Consortium Uk
ARC National repository of clinical serological and genetic material for studies of arthritic and rheumatic diseases.
Specialty: Rheumatology
Node: Edinburgh PI: Joyce Davidson
Node: Aberdeen PI: Wheldon Houlsby

LUPUS REG/jsle
UK Juvenile Systematic Lupus Erythematosus Registry. Clinical characteristics and immunopathology of juvenile systemic lupus erythematosus
Specialty: Rheumatology
Node: Glasgow PI: Gardener Medwin
Node: Edinburgh PI: Gardener Medwin

Microbioma
A Study of airway microbioma in children with and without asthma
Specialty: Respiratory
Node: Aberdeen PI: Steve Turner

MPGN
National study of membranoprolifrative glomerulonephritis
Specialty: Nephrology
Node: Glasgow PI: Heather Maxwell

MRS
Brain Imaging in early infancy and its links to Testosterone
Specialty: Development
Node: Glasgow PI: Martina Rodie

PANTS
Personalized anti-TNF therapy in Crohn's disease.
Specialty: Gastroenterology
Node: Glasgow PI: Richard Russel

PANTS (ex)
Personalized anti-TNF therapy in Crohn's disease. Extension to PANTS study
Specialty: Gastroenterology
Node: Glasgow PI: Richard Russel

PDA Tolerate Trial
Trial of the early treatment of the patent ductus arteriosus versus conservative treatment
Specialty: Neonatal
Node: Glasgow PI: Anne-Marie Heuchan

PERS Observation
Paediatric European risperidone studies; observational pharmacovigilance study
Specialty: Immunology, allergy,
Node: Dundee PI: David Coghill

PRED4
Predicting serious drug side effects in gastroenterology.
Specialty: Nephrology
Node: Glasgow PI: Tariq Ahmad

RaDaR
National Registry of Rare Kidney Diseases
Specialty: Nephrology
Node: Glasgow PI: Heather Maxwell

SEATON
The SEATON study at 15 – a further evaluation of a unique birth cohort.
Specialty: Respiratory
Node: Aberdeen PI: Steve Turner

SIFT
Speed of increasing milk feeds trial.
Specialty: Neonatal
Node: Glasgow PI: Helen Mactier
Node: Glasgow PI: Dr Colin Peters
Node: Glasgow PI: Samuel Ibhanesebhor
Node: Edinburgh PI: Dr Ben Stenson
Node: Ayrshire and Arran PI:

SRNS
National study of steroid resistant nephrotic syndrome in children.
Specialty: Nephrology
Node: Glasgow PI: Heather Maxwell

STOP
Validation of the suicidality: Treatment occurring in paediatrics (STOP) suite of measures in clinical and non-clinical child and adolescent populations.
Specialty: Psychiatry
Node: Dundee PI: Paramala Santosh

TOPS
Timing of primary cleft palate for surgery.
Specialty: Surgery
Node: Edinburgh PI: Felicity Mehendale

TrialNet TN01
Natural history study of the development of Type 1 Diabetes.
Specialty: Diabetes
Node: Aberdeen PI: Amalia Mayo

UK-ChiMES
A prospective cohort study of clinical predictors, disease mechanisms, costs and outcomes of encephalitis in the UK.
Specialty: Neurology
Node: Glasgow PI: Conor Doherty

United Kingdom Paediatric
ITP Registry - Immune thrombocytopenic purpura registry
Specialty: Haematology
Node: Dundee PI:

YOURS
Yorkhill Oligosaccharide Urinaylis Research Study
Specialty: Urology
Node: Glasgow PI: Ruth Addison/Lauren