NCT03520179

Brief Summary

The SMA REACH UK Network is a national and international partnership between doctors and therapists involved in the care of children and adults with Spinal Muscular Atrophy. This network is supported by Biogen and SMA UK.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

9.7 years

First QC Date

January 30, 2018

Last Update Submit

August 16, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physiotherapy assessment using The Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND)

    This is a scale used for the assessment of movement and function of very weak infants with SMA type 1. It consists of 16 items of motor function graded 0-4 with a maximum achievable score of 64.

    1 year

  • Physiotherapy assessment using the Test of Infant Motor Performance Screening Items (TIMPSI)

    This scale assesses motor performance in infants born pre-term to 4 months of age. It consists of 29 items, with 3 item sets (screening, easy and hard sets).

    1 year

Secondary Outcomes (3)

  • Patient´s perception about the condition, interventions performed and Standards of Care assessed by patient interviews

    1 year

  • Patients perception about the condition, interventions performed and Standards of Care assessed using the Paediatric Outcomes Data Collection Instrument (PODCI)

    1 year

  • Patients perception about the condition, interventions performed and Standards of Care assessed using the Egan Klassifikation Scale (EK2)

    1 year

Study Arms (3)

SMA TYPE 1

genetically confirmed SMA

SMA TYPE 2

genetically confirmed SMA

SMA TYPE 3

genetically confirmed SMA, Ambulant and non-ambulant

Eligibility Criteria

Age0 Months - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with genetically confirmed SMA types 0, I, II and III (ambulant and non-ambulant) followed at each open and recruiting neuromuscular centre.

You may qualify if:

  • It will be genetically confirmed SMA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dubowitz Neuromuscular Centre

London, WC1N 1EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Central Study Contacts

Salma Samsuddin

CONTACT

MariaCristina Scoto

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

May 9, 2018

Study Start

December 17, 2013

Primary Completion

August 12, 2023

Study Completion

August 12, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations