Image

Neuromuscular Characterisation in Late Adolescent and Adult Cystinosis Patients

Recruiting
16 years of age
Both
Phase N/A

Powered by AI

Overview

The primary objective of the study is to evaluate the change in motor function of patients with cystinosis.

The secondary objectives of the study:

  • assessment of the respiratory function;
  • assessment of the muscle function;
  • assessment of swallowing disorders;
  • assessment radiologically of the muscular efficiency;
  • assessment of lean mass / fat mass ratio;
  • assessment of sleeping disorders;
  • annual assessment of evolution of above functions.

All patients will be examined by experienced neuromuscular specialist (Pr Pascal Laforêt) and pulmonologist specialized in neuromuscular disorders (Pr Hélène Prigent). All evaluations will be performed in Raymond-Poincaré hospital (Teaching hospital of Assistance Publique - Hopitaux de Paris (APHP) and University of Paris-Saclay) neuromuscular center, coordinated by Pr Pascal Laforêt.

Description

This is a monocentric study. The enrollment will be performed as routine care in the department of neurology - neuromuscular center of Raymond Poincaré hospital (APHP).

Patients with cystinosis will be consecutively invited to participate in the study until 20 patients are included. This will avoid selection bias if any. For eligible non included patients, a specific non-identifying registry will be set-up with a very restricted number of variables indicative of disease severity at baseline, allowing for a comparison of included and non-included patients.

Participating cystinosis patients will be proposed to attend a one-day hospitalization. Evaluations will be performed during stable state upon baseline and during a follow-up visit 12 months later.

The study expected duration is 30 months with 18 months for patients' inclusion and 12 month-follow-up.

Eligibility

Inclusion Criteria:

  • Patients aged ≥ 16 years;
  • Genetically confirmed diagnosis of cystinosis;
  • Presenting motor deficiency of at least one muscle;
  • Covered by health insurance.

Exclusion Criteria:

  • Patient refusal;
  • Foreign patients under AME health schema;
  • Patients under legal protection;
  • Pregnancy or breast-feeding.

Study details

Cystinosis

NCT05545774

Assistance Publique - Hôpitaux de Paris

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.