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Paediatric Studies

The Children’s Research network portfolio of clinical trials includes medical, interventional and observational studies in all specialties within paediatrics. It has both commercial and non-commercial funded studies, international studies of new medicines, repurposing of existing medicines for different conditions and academic studies investigating the causes and progression of medical conditions throughout childhood.   

We also support interventional studies on new and emerging technologies. For any information on how to get support for you study contact the Network Manager p.dicks@abdn.ac.uk.

 

Feature on Neurology

Neurology is an important specialty within our portfolio of studies. Two conditions we have studies open and recruiting in are migraine (chronic and episodic) and epilepsy. 

Migraine

Migraine is a common condition associated with moderate to severe headaches. Approximately 8% of children and teens live with migraine. Unlike adults, children and teens may have a more difficult time understanding the pain and disruption their headaches cause, such as being unable to concentrate at school or participate in extracurricular activities.

New medications have been licensed to treat migraine in adults and there are now several studies that are investigating their efficacy and safety in children and young people living with episodic or chronic migraine.

Current studies

  • Prospect-1: Interventional, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine
  • Prospect-2: Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine

The aim of the PROSPECT-1 and PROSPECT-2 are to see if the study medicine eptinezumab, can reduce the number of headache days per month in children and teens aged 6-17. The study will last around 24 weeks with an invitation to extend study treatment to one year in total. Participants will be randomly assigned to receive one of two doses of the study medicine or placebo.

All participants will be randomised to one of three groups, with a two in three chance of receiving the study medicine. Using placebo is often required in clinical studies to scientifically compare and prove that the study medicine works.

A long-term extension study allows those who received placebo to be entered into the treatment arm.

These studies are running in the Royal Hospital for Children Glasgow and the Royal Hospital for Children and Young People Edinburgh contact our lead nurses Susanne Cathcart and Maxine Ramsay for more information.

KALEIDOSCOPE

A phase 3, multicentre, 12-week, double blind, placebo-controlled study to evaluate the safety and efficacy of atogepant for the preventive treatment of episodic migraine in paediatric patients  6 to 17 years of age

The main goal of this study is to evaluate the safety and tolerability of atogepant in children with episodic migraine. The drug is already licenced for use in adults.  This drug is a preventative treatment taken regularly to try and reduce the incidence of migraine episodes. The trial includes a long term extension with access to the medication for 52 weeks.

This trial is running in the Royal Aberdeen Children's Hospital Aberdeen, to find out more contact the lead nurse Margaret Connon.

 

Epilepsy

Epilepsy is a neurological condition characterized by recurrent, unprovoked seizures, which are caused by abnormal electrical activity in the brain. It is often diagnosed when a person has two or more seizures without an identifiable cause. While the exact cause of epilepsy can vary, it is generally considered a chronic brain disorder that affects how nerve cells communicate. Although there is no cure for epilepsy, various treatment options are available to help manage the condition. 

The SCN1A Horizons study is running in the children’s clinical research facilities in Dundee, Glasgow, Aberdeen and Edinburgh. The SCN1A Horizons Natural History Study is a registry that will collect health information from up to 400 children and adults with SCN1A-related epilepsy, such as Dravet Syndrome, over three-years. It will study how people from across the UK, who have SCN1A-related epilepsy, experience the condition. 

This research will allow us to learn more about the seizures, learning abilities and behavioural difficulties that children and adults with Dravet Syndrome live with. This will help health professionals to choose treatments that improve someone’s quality of life, as early as possible.

Study visits can happen in person or remotely via video link. To find out more contact your nearest participating site or contact the study team at SCN1AHorizons@glasgow.ac.uk.

 

Network Highlight 

The BronchStart Study demonstrated the value of close collaboration and communication across the network to rapidly open the study in Aberdeen, Ayrshire and Arran, Dundee, Edinburgh and Glasgow children's hospitals recruiting mothers whose babies were admitted to hospital with respiratory symptoms.

Respiratory syncytial virus (RSV) is the single main infectious cause of hospitalisation to infants in the United Kingdom. In June 2024 the governments of Scotland, England, Wales and Northern Ireland announced that RSV vaccination for pregnant women would be rolled out across the United Kingdom, starting on August 12 2024 (Scotland) and September 1, 2024 (England/Wales/Northern Ireland).

The BronchStart collaboration recognised this as a unique opportunity to identify potential obstacles to vaccine rollout, understand the effectiveness of this new vaccine, and understand whether viral evolution could threaten the effectiveness of vaccination.

Thanks to the hard work of research teams across Scotland and England, by January 29, 2025 they had published preliminary data on maternal views on vaccination, showing that mothers were in general very positive about the new vaccination, but many had faced logistical challenges in accessing this. Initial vaccine effectiveness estimates were shared with Public Health Scotland, UKHSA, JCVI and the World Health Organisation, and data from the study used for a ministerial briefing. The preprint of these estimates is now publicly available; the study recruited infants of a wide range of socio-economic status, and 20% of mothers recruited were of non-white ethnicity. Ongoing work will sequence RSV positive samples from recruited infants to understand the role of viral variability in vaccine effectiveness. 

The study demonstrates the value of the rapid roll-out of a research study in capturing a diverse, representative population and generating data that can have tangible, real-world impact.