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 : February 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Optic Neuritis Optic; Neuritis, With Demyelination | Drug: ACT-01 IV administration Other: Placebo IV administration | Phase 2 |
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 : | October 30, 2023 |
Estimated Study Completion Date : | March 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Multidose ACT-01
Once daily IV infusions of ACT-01 (n=18) for 5 consecutive days
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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 |
- Safety and tolerability: adverse events [ Time Frame: up to 6 months ]To determine if ACT-01 treatment is associated within increase of adverse event
- 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
- 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
- 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

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

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
Contact: Jennifer Thibault, MSc | jennifer.thibault@icm-institute.org | ||
Contact: STEPHANE PARIS, MSc | sparis@accure.health |
France | |
CIC Neurosciences - La Pitié Salpêtrière | Recruiting |
Paris, France, 75013 |
Study Director: | Rossella Medori, MD | Accure Therapeutics |
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: | February 24, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acute Optic Neuritis (AON) Demyelination Optic Neuritis |
Neuritis Optic Neuritis Demyelinating Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases |