NCT04686110

Brief Summary

Amyotrophic Lateral Sclerosis, or Charcot's disease, is a neurodegenerative disease affecting motor neurons. The disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in France. The only therapeutic treatment available to date in France is riluzole, which slows the progression of the disease. Amyotrophic Lateral Sclerosis is the first degenerative disease affecting motor neurons. However, recent evidence suggests that the impairment extends beyond motor neurons alone. Optical Coherence Tomography analyzes made it possible to highlight ophthalmologic damage in patients with Amyotrophic Lateral Sclerosis, in particular at the macula and papilla, although some results are contradictory. No angiographic Optical Coherence Tomography analysis has been performed to date in patients with Amyotrophic Lateral Sclerosis. However, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in Amyotrophic Lateral Sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.

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
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

December 22, 2020

Last Update Submit

October 7, 2021

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls

    Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls

    at inclusion

Study Arms (2)

Patients Amyotrophic Lateral Sclerosis

OTHER
Other: angiographic optical coherence tomography

Control subjects

OTHER
Other: angiographic optical coherence tomography

Interventions

angiographic optical coherence tomographyOTHER

angiographic optical coherence tomography

Control subjectsPatients Amyotrophic Lateral Sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient Amyotrophic Lateral Sclerosis :
  • Patient diagnosed with bulbar or spinal ALS defined according to El Escorial criteria (probable or certain)
  • Hospitalized in a day hospital at the Angers University Hospital as part of his usual follow-up
  • Control subject :
  • Subject not affected by the disease studied and without a history of neurological disease.
  • Subject matched in age and sex to a case (patient)
  • For all participants:
  • Signature of informed consent to participate in the protocol

You may not qualify if:

  • Patient Amyotrophic Lateral Sclerosis and control subject :
  • Simultaneous participation in another intervention protocol with an experimental treatment
  • Subject unable to express consent
  • Known ophthalmologic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the etiology)
  • Diabetic subject
  • Cardiovascular history
  • Inability to perform the ophthalmological examinations of the study
  • Pregnant, lactating or parturient woman
  • Subject under duress psychiatric care
  • Subject to legal protection
  • Subject not affiliated or not beneficiary of a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Attachée de Recherche Clinique

CONTACT

0241353637jeanne.muller@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

February 12, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

FR(1)