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

NCT ID: NCT05407428

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-10-28

Brief 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. The evaluations will include ALSFRS-R examination, as well as an oculometric evaluation for eye movements.

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

NeuraLight software-based platform

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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:

1. 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

2. NYHA Class II or greater congestive heart failure

3. Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications

4. Poorly controlled or brittle diabetes mellitus

5. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuraLight

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian Drory, MD

Role: PRINCIPAL_INVESTIGATOR

Sackler Faculty of Medicine, Tel Aviv University

Locations

Sourasky medical center

Tel Aviv, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 30198218 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35448020 (View on PubMed)

Other Identifiers

NL/ALS/2022-2

Identifier Type: -

Identifier Source: org_study_id