Last reviewed · How we verify

NCT04602195: NusiMFM

Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen

Completed Last updated 21 December 2023
What this trial tests

trial in Spinal Muscular Atrophy in 33 participants. Completed in 10 November 2023.

Timeline
19 January 2021
Primary endpoint
10 November 2023
10 November 2023

Quick facts

Lead sponsorHospices Civils de Lyon
StatusCompleted
Study typeOBSERVATIONAL
Enrollment33
Start date19 January 2021
Primary completion10 November 2023
Estimated completion10 November 2023
Sites10 locations across France

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 2 to 6, any sex, with Spinal Muscular Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items originally validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items originally validated for patients between 2 and 6 years old (MFM-20). In order to prove the possible use of MFM-32 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-32 and the validity of the scale in this population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacological Therapies of Spinal Muscular Atrophy: A Narrative Review of Preclinical, Clinical-Experimental, and Real-World Evidence.
    Crisafulli S, Boccanegra B, Vitturi G, Trifirò G, et al · · 2023 · cited 11× · PMID 37891814 · DOI 10.3390/brainsci13101446

Verify or expand the search:

Other recruiting trials for Spinal Muscular Atrophy

Currently open trials in the same condition.

Other Hospices Civils de Lyon trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04602195.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing