Amyotrophic Lateral SclerosisCAPISLANCT04686110
Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis - CAPISLA
A study testing angiographic optical coherence tomography in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- angiographic optical coherence tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2021to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- For all participants:
- Major upon inclusion
- Signature of informed consent to participate in the protocol
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, 49933
Jeanne Muller, 0241353637
About this study
Official title: Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- angiographic optical coherence tomography
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiographic optical coherence tomographyOther
angiographic optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Patients Amyotrophic Lateral Sclerosis | Other | Not described Receives: Other: angiographic optical coherence tomography |
| Control subjects | Other | Not described Receives: Other: angiographic optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start12 Feb 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686110
- Sponsor's protocol ID
- 2020-AO3395-34
- Acronym
- CAPISLA
- Status last verified
- Oct 2021
- First submitted
- 22 Dec 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04686110
- Acronym / sponsor ID
- CAPISLA / 2020-AO3395-34
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Amyotrophic Lateral Sclerosis | Other | Other: angiographic optical coherence tomography |
| Control subjects | Other | Other: angiographic optical coherence tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Subject not affected by the disease studied and without a history of neurological disease.
- Subject matched in age and sex to a case (patient)
- Major upon inclusion
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angiographic optical coherence tomographyangiographic optical coherence tomography | Other | Control subjects, Patients Amyotrophic Lateral Sclerosis |
Primary outcome
Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls
Time frame: at inclusion
Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angiographic optical coherence tomography in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Attachée de Recherche Clinique (0241353637, jeanne.muller@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.