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

PHASE2TerminatedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

November 23, 2018

Primary Completion Date

April 27, 2022

Study Completion Date

July 12, 2022

Conditions
Relapsing Remitting Multiple SclerosisOptic NeuropathyOptic; Neuritis, With Demyelination
Interventions
DRUG

CNM-Au8

CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.

DRUG

Placebo

Placebo is liquid with identical color and taste

Trial Locations (7)

2305

John Hunter Hospital, New Lambton Heights

3004

Alfred Health, Melbourne

4102

Princess Alexandria Hospital, Woolloongabba

7000

Menzies Institute for Medical Research, Hobart

75390

UT Southwestern Medical Center, Dallas

Unknown

Sydney Brain Mind Centre, Sydney

V6T 1Z3

University of British Columbia, Vancouver

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Clene Australia Pty Ltd.

INDUSTRY

lead

Clene Nanomedicine

INDUSTRY