UK SMA Patient Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNewcastle University

About this trial

Spinal muscular atrophy (SMA) is a form of motor neuron disease, most commonly caused by a mutation in the survival motor neuron 1 gene (SMN1) which results in a wide disease spectrum affecting children and adults. It is an autosomal recessive disorder and is therefore caused by inheritance of a mutated gene from each parent. All forms of SMA have an estimated combined incidence of 1 in 6,000 to 1 in 10,000 live births, with a carrier frequency of 1/40 to 1/60.

The patient registry aims to facilitate a questionnaire-based research study in order to better characterise and understand the disease in the UK and in Ireland. Entry is via self-registration over a secure internet connection (https://www.sma-registry.org.uk/). Online, patients are asked to read an information sheet about the research project and then indicate their consent to demonstrate willingness to participate. Following online consent, subjects will be entered into the registry. This is an on-going database and all participants are invited to update their information on a biannual basis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients with a confirmed SMA diagnosis (or pending diagnosis) are eligible for inclusion. Diagnosis will be confirmed via genetic testing results

Disqualifiers

There are no exclusion criteria for the registry

Trial population

Participants with SMA will volunteer to participate in this study. The study will be advertised through neuromuscular disease clinics, the registry website, patient organisations and conferences throughout the UK and Ireland.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Patient Registry

    Other intervention

    Participants who have volunteered to participate will complete various questionnaires relating to their conditions.

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Participants with Spinal Muscular Atrophy1 intervention

Trial outcomes

Primary outcomes

1

Patient questionnaire

Patient-reported clinical and genetic confirmation of SMA, symptoms relating to muscle weakness, motor function, medication and family history. The patient registry collects the TREAT-NMD Expanded SMA Core Dataset, which includes post-marketing surveillance data items, and patient-reported outcome measures (PROMs).

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Newcastle University

Lead sponsor

Biogen

Collaborator

Roche Pharma AG

Collaborator

Adult SMA REACH

Collaborator

SMA REACH UK

Collaborator