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Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis (VISIONARY-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536559
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Clene Australia Pty Ltd
Information provided by (Responsible Party):
Clene Nanomedicine

Brief 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 the improvement in remyelination as measured by visual evoked potentials after 24 weeks of treatment. The secondary endpoint is the improvement in low contrast vision as measured by low contrast letter acuity after 24 weeks of treatment.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Optic Neuropathy Optic; Neuritis, With Demyelination Drug: CNM-Au8 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, parallel group, placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The drug formulations will be identical in appearance (size, shape, volume, color) and smell. The packaging and labeling will be designed to maintain blinding to the Investigator's team and to patients. There are no visible differences between the active drug, and placebo dosing units
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, DB-PC, Parallel Group Study for the Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of CNM-Au8 For Remyelination In Multiple Sclerosis
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : March 30, 2020


Arm Intervention/treatment
Experimental: 15mg CNM-Au8
15mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water
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.

Experimental: 30mg CNM-Au8
30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water
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.

Placebo Comparator: Placebo
The matched placebo to be used in this study will consist of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatments.
Drug: Placebo
Placebo is liquid with identical color and taste




Primary Outcome Measures :
  1. Multifocal Visual Evoked Potential (mfVEP) Latency [ Time Frame: At six month (24-weeks) ]
    mfVEP latency is an electrophysiologic measure of remyelination that assesses the speed of conduction of electrical signals in neurons of the visual system.


Secondary Outcome Measures :
  1. Low Contrast Letter Acuity (LCLA) [ Time Frame: At six months and then every 12 weeks thereafter, up to 48-weeks ]
    LCLA is a functional measure of contrast vision


Other Outcome Measures:
  1. Multifocal Visual Evoked Potential (mfVEP) Latency [ Time Frame: Every 12 weeks following the 6-month primary endpoint, up to 48-weeks ]
    mfVEP latency is an electrophysiologic measure of remyelination that assesses the speed of conduction of electrical signals in neurons of the visual system.

  2. Multifocal Visual Evoked Potential (mfVEP) Amplitude [ Time Frame: Every 12 weeks following the 6-month primary endpoint, up to 48-weeks ]
    mfVEP amplitude is an electrophysiologic measure of axonal protection that assesses the magnitude of electrical signals in neurons of the visual system.

  3. Full field Visual Evoked Potentials (ff-VEP) latency [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    ffVEP latency is an electrophysiologic measure of remyelination that assesses the latency of electrical signals conduction in neurons of the visual system.

  4. Full field Visual Evoked Potentials (ff-VEP) amplitude [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    ffVEP amplitude is an electrophysiologic measure of axonal protection that assesses the magnitude of electrical signals in neurons of the visual system.

  5. Optical Coherence Tomography (OCT) [ Time Frame: At three month intervals beginning at 24-weeks, up to 48-weeks ]
    Measure of optic nerve morphology and retinal layers

  6. Magnetic Resonance Imaging (MRI) [ Time Frame: At three month intervals beginning at 24-weeks, up to 48-weeks ]
    Structural imaging of MS lesions

  7. High Contrast Visual Acuity Testing (HCVA) [ Time Frame: Every 6-weeks, up to 48-weeks ]
    Standard visual acuity testing

  8. Expanded Disability Status Scale (EDSS) [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    Standardized MS functional scales

  9. Multiple Sclerosis Functional Composite Scale (MSFC) [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    Standardized MS functional scales

  10. Symbol Digit Modality Test (SDMT) [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    Pattern matching functional scale

  11. National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    Visual Function Quality of Life Scales

  12. Ten-item Neuro-Ophthalmic Supplement (10-item NOS) [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    Visual Function Quality of Life Scales

  13. Six-Minute Walk Test (6MWT) [ Time Frame: At three month intervals beginning at 12-weeks, up to 48-weeks ]
    Standardized Measure of Mobility and Exercise Tolerance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age and up to 50 years of age (inclusive).
  2. Clinical diagnosis of MS (meeting McDonald criteria, 2010) who have had RRMS no longer than 10 years from diagnosis.
  3. Presence of chronic optic neuropathy defined by clinical and/or multifocal visual evoked potential (mf-VEP) criteria.
  4. Retinal Nerve Fiber Layer (RNFL) thickness > 70 μm.
  5. Stable disease activity based on the Investigator's judgment over the prior 12 months.
  6. Able to understand and give written informed consent.

Exclusion Criteria:

  1. An acute optic neuritis episode or systemic steroid treatment within the prior 6 months.
  2. MS-related clinical relapse requiring systemic steroid treatment within the prior 12 months.
  3. Unstable treatment with a disease modifying therapy (DMT) defined as a treatment change within prior 3-months unless due to intolerability.
  4. Any immunosuppression therapy other than those approved for the treatment of MS.
  5. Any drug known or suspected of producing retinal or optic nerve toxicity including hydroxychloroquine, chloroquine, clofazimine, vigabatrin, or ethambutol.
  6. Any active ophthalmological causes for retinal damage other than MS.
  7. Diabetes with retinopathy or a previous diagnosis of Diabetes Mellitus or history of prior impaired fasting glucose ≥126 mg/dL (or ≥ 200 mg/dL after oral glucose tolerance test).
  8. History of human immunodeficiency virus (HIV), hepatitis C (HepC) virus antibody, or hepatitis B (HepB) virus antibody.
  9. History of gold allergy.
  10. Patients taking stimulant medications (including: amphetamine, dextroamphetamine, lisdexamfetamine, methylphenidate, or modafinil).
  11. Patients taking clemastine fumarate or 4-aminopyridine (fampridine).
  12. Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
  13. History or evidence of substance abuse or alcohol abuse within 5 years prior to Screening, including alcoholism; or severe tobacco use (>1 pack/day).
  14. Clinical history of toxic neuropathy (e.g., secondary to treatment with ethambutol, isoniazid, linezolid, gentamycin, chloramphenicol, vincristine, or penicillamine).
  15. Current enrollment in any other drug or device treatment study within 3 months prior to Baseline. Participation in an observational non-interventional study (i.e., no drug or device therapy) is not an exclusion criterion.
  16. Inability to undergo any planned study procedures such as VEP or MRI, including reduced renal clearance (screening: GFR < 45 mL/min), history of severe hypersensitivity to gadolinium-DTPA, claustrophobia; or inability to comply with study requirements based on Investigator judgment.
  17. Based on the investigator's judgment, concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments.

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): NCT03536559


Contacts
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Contact: Glen Frick, MD, PhD 801-676-9695 info@clene.com
Contact: Austin Rynders 801-676-9695 info@clene.com

Locations
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Australia, New South Wales
Sydney Brain Mind Centre Recruiting
Sydney, New South Wales, Australia
Contact: Heidi Beadnall, MD       heidi@sydneyneurology.com   
Sponsors and Collaborators
Clene Nanomedicine
Clene Australia Pty Ltd
Investigators
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Principal Investigator: Heidi Beadnall, MD University of Sydney

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Responsible Party: Clene Nanomedicine
ClinicalTrials.gov Identifier: NCT03536559    
Other Study ID Numbers: CNMAu8.201
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clene Nanomedicine:
gold
nanocrystal
multifocal visual evoked potential
full field visual evoked potential
low contrast vision
low contrast letter acuity
remyelination
demyelination
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Optic Nerve Diseases
Neuritis
Demyelinating Diseases
Optic Neuritis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Cranial Nerve Diseases
Eye Diseases