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ACT-01 in Patients With Acute Optic Neuritis (ACUITY)

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ClinicalTrials.gov Identifier: NCT04762017
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Neurotrials
Information provided by (Responsible Party):
Accure Therapeutics

Brief Summary:
To evaluate the safety and tolerability of ACT-01 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care.

Condition or disease Intervention/treatment Phase
Optic Neuritis Optic; Neuritis, With Demyelination Drug: ACT-01 IV administration Other: Placebo IV administration Phase 2

Detailed Description:
ACUITY is a phase 2a, monocentric, two-arm, randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of ACT-01 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. Thirty-six eligible subjects aged 18 to 60, with recent onset (visual loss symptoms) of unilateral AON (idiopathic or associated with multiple sclerosis) will be randomized to receive ACT-01 or placebo

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Two-arm, Randomized, Double-blind, Placebocontrolled, Monocentric Study to Evaluate the Safety and Tolerability of ACT-01 Compared to Placebo in Patients With Acute Optic Neuritis
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : August 25, 2021
Estimated Study Completion Date : December 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multidose ACT-01
Once daily IV infusions of ACT-01 (n=18) for 5 consecutive days
Drug: ACT-01 IV administration
Multiple Dose of ACT-01 IV administration for 5 consecutive days

Placebo Comparator: Placebo
Once daily IV infusions of Placebo (n=18) for 5 consecutive days
Other: Placebo IV administration
Placebo IV administration for 5 consecutive days




Primary Outcome Measures :
  1. Safety and tolerability: adverse events [ Time Frame: up to 6 months ]
    To determine if ACT-01 treatment is associated within increase of adverse event


Secondary Outcome Measures :
  1. Neuroimaging [ Time Frame: up to 12 months ]
    Change in ganglion cell and inner plexiform layer thickness in the affected eye measured with optical coherence tomography (OCT) compared to baseline in the affected eye

  2. Neuroimaging [ Time Frame: up to 12 months ]
    Change in Retinal Nerve Fibre Layer thickness in the affected eye measured with OCT compared to baseline in the affected eye

  3. Visual Acuity [ Time Frame: Up to 12 months ]
    Change on the 2.5% Early Treatment Diabetic retinopathy study (ETDRS) Low Contrast Letter Acuity chart and ETDRS high contrast visual acuity measured in the affected eye compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Diagnosed with a unilateral acute optic neuritis with a demyelinating origin
  • Onset of visual loss symptoms in the last 10 days before randomization

Main Exclusion Criteria:

  • Optic neuropathy of non-demyelinating origin
  • Known Neuromyelitis optica with autoantibodies against aquaporin-4 (AQP4-Abs)
  • Patients with widespread and symmetric white matter alterations in the screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders)
  • Active, chronic disease (or stable but treated with immune therapy) of the immune system other than MOG antibody associated disorder (MOGAD) or Multiple Sclerosis (MS) (e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency)
  • An alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss.
  • Diagnosed with macular oedema, severe myopia (>6 δ) or other disease of the retina at inclusion
  • Known diabetic retinopathy
  • Known glaucoma
  • Female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study.
  • Male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration.
  • Breastfeeding or pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762017


Contacts
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Contact: Jennifer Thibault, MSc jennifer.thibault@icm-institute.org
Contact: STEPHANE PARIS, MSc sparis@accure.health

Locations
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France
CIC Neurosciences - La Pitié Salpêtrière Recruiting
Paris, France, 75013
Sponsors and Collaborators
Accure Therapeutics
Neurotrials
Investigators
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Study Director: Rossella Medori, MD Accure Therapeutics
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Responsible Party: Accure Therapeutics
ClinicalTrials.gov Identifier: NCT04762017    
Other Study ID Numbers: ACT-01_P2_01
2020-003147-29 ( EudraCT Number )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Accure Therapeutics:
Acute Optic Neuritis (AON)
Demyelination
Optic Neuritis
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases