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Amyotrophic Lateral SclerosisNCT05407428

A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in ALS Patients

An observational study of Amyotrophic Lateral Sclerosis, run by NeuraLight at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective study in a cohort of about 45 patients with ALS participating in the Neurosense PrimeC drug study (NCT05357950). This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated every 2 months during a time period of 18 months. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
NeuraLight software-based platform
How many people
45 participants
Where
1 siteIsrael
Study dates
31 May 2022to 28 Oct 2024
Phase
Observational
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: About 45 ALS patients, ages 18-75 years with familial or sporadic ALS, according to the Gold Coast Criteria, who are recruited and participating in the PrimeC drug study (NCT05357950)

Who may be able to join

  • Able to comprehend and willing to sign an informed consent form (ICF)
  • Males or females between the ages of 18 and 75 years of age, inclusive
  • Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the Gold Coast criteria)
  • Disease duration after first symptom (muscle weakness) less than 30 months prior to screening
  • Pre-enrollment ALSFRS-R slope from disease onset ≥ 0.3 points per month
  • ALSFRS-R at screening ≥ 25
Show all 12Show fewer
  • Item 3 (swallowing) in ALSFRS-R ≥ 3
  • Subjects may be treated in parallel with Riluzole and/or Edaravone and/or Sodium Phenylbutyrate; 30 days of stable use prior to enrollment is required
  • Upright slow vital capacity (SVC) ≥ 60% of predicted for age, height, weight and sex at screening according to the GLI-2012
  • 18 < BMI < 30
  • A caregiver (if one is needed)
  • Female subjects must be post-menopausal (≥ 1 year) OR sterilized, OR if of childbearing potential (i.e., females who have had their first period unless they are anatomically or physiologically incapable to become pregnant), must have a negative pregnancy test, and agree to use contraceptive drugs or devices (e.g., diaphragm plus spermicide, or oral contraceptives) for the duration of the study and 10 weeks after the last treatment dose AND require male partners to use a condom during sexual intercourse

Who cannot join

  • A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
  • Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder and/or bariatric surgery Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
  • Known or suspected symptomatic congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
  • Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval
  • Known or suspected diagnosis or family history of epilepsy in first degree relatives
  • Known predisposition to tendinitis
Show all 19Show fewer
  • Tracheostomy or percutaneous gastrostomy use
  • Presence at screening of any medically significant cardiac, pulmonary, musculoskeletal, or psychiatric illness that might interfere with the subject's ability to comply with study procedures or that might confound the interpretation of clinical safety data, including, but not limited to:
  • Mean systolic blood pressure >160 mm Hg and/or mean diastolic blood pressure >100 mm Hg (measurements taken after a few minutes rest) that persist on 3 successive measurements taken at least 2 minutes apart
  • NYHA Class II or greater congestive heart failure
  • Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
  • Poorly controlled or brittle diabetes mellitus
  • Cognitive impairment, related to ALS or otherwise, sufficient to impair subject's ability to understand and/or comply with study procedures and provide informed consent
  • Subject who is treated with chronic aspirin or NSAIDs and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
  • Any contraindication for ciprofloxacin and celecoxib according to the current prescribing information.
  • Female who is pregnant or breastfeeding or with intention of becoming pregnant during the course of the study.
  • Any impairment or social circumstance that, in the opinion of the Investigator, would render the subject not suitable to participate in the study.
  • Subject, or subject's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study.
  • Subject is participating in (or plans to participate in) any other investigational drug trial, or plans to be exposed to any other investigational agent, device and/or procedure, from 30 days prior to Screening through study completion.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sourasky medical center

    Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: An Prospective Study in a Cohort of Amyotrophic Lateral Sclerosis (ALS) Patients Participating in a Phase IIb Drug Study (NCT05357950) to Evaluate the Correlation Between Oculometric Measurements and ALS Functional Rating Scale (ALSFRS-R)

This is a prospective study in a cohort of about 45 patients with ALS participating in the Neurosense PrimeC drug study (NCT05357950).

This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated every 2 months during a time period of 18 months. The evaluations will include ALSFRS-R examination, as well as an oculometric evaluation for eye movements.

Read the detailed description

This is an observational prospective study in a cohort of about 45 patients with ALS participating in the Neurosense PrimeC drug study (NCT05357950), which is a Phase IIb, Randomized, Prospective, Double-Blind, Placebo-Controlled Study, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects with ALS. The subjects are males or females with familial or sporadic ALS of no more than 30 months disease duration, who meet the inclusion criteria of the PrimeC drug study, provide a signed an Informed consent and are willing and able to comply with study's procedures including follow-up visits.

This study is designed to evaluate the correlation between oculometric measures and the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). Subjects will be evaluated every 2 months during a time period of 18 months. The evaluations will include an ALSFRS-R examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.

Being tested
NeuraLight software-based platform
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.

  • NeuraLight software-based platformOther

    NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including ALS patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between ALSFRS-R score and its parts with NeuraLight oculometric measurements

    The correlation between ALSFRS-R score and its parts with NeuraLight oculometric measurements (R-Square>0.5, p<0.05) according to the measured ALS functional rating scale - revised (ALSFRS-R) at every visit

    Measured: 18 months

  2. Feasibility of using NeuraLight system to capture oculometric measures in a cohort of ALS patients

    Capturing >50 different oculometric measures in >95% of a cohort of 45 patients

    Measured: 18 months

  3. Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system

    Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1

    Measured: 18 months

Secondary outcomes (1)

  1. Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of ALSFRS-R clinical endpoint

    Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of ALSFRS-R with a relative root mean square error (RMSE) of <0.1

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start31 May 2022
  3. Primary completion28 Oct 2024
  4. Study completion28 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407428
Sponsor's protocol ID
NL/ALS/2022-2
Status last verified
Oct 2024
First submitted
29 May 2022
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not plan to share IPD with other researchers

Publications

  • Kang BH, Kim JI, Lim YM, Kim KK. Abnormal Oculomotor Functions in Amyotrophic Lateral Sclerosis. J Clin Neurol. 2018 Oct;14(4):464-471. doi: 10.3988/jcn.2018.14.4.464. Epub 2018 Jun 27.

    PubMed 30198218

  • Guo X, Liu X, Ye S, Liu X, Yang X, Fan D. Eye Movement Abnormalities in Amyotrophic Lateral Sclerosis. Brain Sci. 2022 Apr 11;12(4):489. doi: 10.3390/brainsci12040489.

    PubMed 35448020

  • Berkman O, Raveh E, Harpaz E, Kreitman R, Ben-Ami E, Nechushtan E, Birman N, Drory VE. Changes in saccadic intrusions over time as an objective biomarker to follow ALS disease progression. Amyotroph Lateral Scler Frontotemporal Degener. 2024 Nov;25(7-8):760-766. doi: 10.1080/21678421.2024.2376732. Epub 2024 Jul 8.

    PubMed 38975625

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by NeuraLight at 1 site in Israel.

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 12 inclusion and 19 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: finished, as of the sponsor's last update on 30 Oct 2024. 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 Israel. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between ALSFRS-R score and its parts with NeuraLight oculometric measurements (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407428, which also lists 3 linked publications.

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 30 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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