TerminatedPhase 2

Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis

Stopped: COVID-19 related enrollment challenges.

United States, Australia73 participantsStarted 2018-11-23

Plain-language summary

The objective of this trial is to assess the efficacy and safety of CNM-Au8 as a remyelinating treatment for vision-impairing MS lesions in participants who have chronic vision impairment as a result of Relapsing-Remitting Multiple Sclerosis. The primary endpoint is to assess the efficacy and safety of CNM-Au8 as a remyelinating therapy in patients with stable RMS. The secondary endpoint is Change in Functional Composite Responder Analysis Score from Baseline to Week 24.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. At least 18 years of age and up to 55 years of age (inclusive) at Screening.
✓. Clinical diagnosis of Relapsing Multiple Sclerosis (meeting McDonald criteria, 2010) who have had RMS no longer than 15 years from diagnosis.
✓. Maximum Best Corrected High Contrast Visual Acuity (BC-HCVA) deficit on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart of 20/200 (6/60 metric) in both eyes.
✓. Best Corrected Low Contrast Letter Acuity (BC-LCLA) (by 2.5% Sloan Chart) must be 20/40 (6/12 metric) (inclusive) or worse in the affected eye and 20/32 (6/9.5 metric) or worse in the fellow eye; and the BC-LCLA must be worse than BC-HCVA for the respective value in both eyes.
✓. Retinal Nerve Fiber Layer (RNFL) thickness ≥ 70 μm.
✓. Stable disease activity based on the investigator's judgment over the previous 6 months.
✓. All hematological parameters and biochemical parameters that fall outside the Within Normal Limits range must be assessed as Not Clinically Significant (NCS) and deemed stable or transient in nature.
✓. Able to understand and give written informed consent.

Exclusion criteria

What they're measuring

Measures of Visual Function

Timeframe: Baseline to 48 weeks

Trial details

NCT IDNCT03536559

SponsorClene Nanomedicine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-27

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