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

Primary Purpose

Relapsing Remitting Multiple Sclerosis, Optic Neuropathy, Optic; Neuritis, With Demyelination

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CNM-Au8
Placebo
Sponsored by
Clene Nanomedicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring gold, nanocrystal, multifocal visual evoked potential, full field visual evoked potential, low contrast vision, low contrast letter acuity, remyelination, demyelination

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years of age and up to 55 years of age (inclusive) at Screening.
  2. Clinical diagnosis of Relapsing Multiple Sclerosis (meeting McDonald criteria, 2010) who have had RMS no longer than 15 years from diagnosis.
  3. 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.

    a. BC-HCVA is defined as the last line on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart that a patient is able to read three (3) or more letters correctly.

  4. 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.

    a. BC-LCLA is defined as the last line on the 2.5% Sloan Chart that a patient is able to read three (3) or more letters correctly.

  5. Retinal Nerve Fiber Layer (RNFL) thickness ≥ 70 μm.
  6. Stable disease activity based on the investigator's judgment over the previous 6 months.
  7. 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.
  8. Able to understand and give written informed consent.

Exclusion Criteria:

  1. History of AQP4, MOG Ab(+) status, or ≥ 3 segments lesion in the spinal cord.
  2. Any diagnosis other than RMS that could explain the patient's signs and symptoms.
  3. An acute optic neuritis episode within the prior 6 months.
  4. Clinical relapse requiring systemic steroid treatment within the prior 3 months (pre- treatment with systemic steroids during the administration of disease-modifying therapies [DMT] may be allowed after discussion with the Sponsor's Medical Monitor but must not be administered within 30 days of a planned VEP or MRI assessment).
  5. Unstable treatment with a disease-modifying therapy (DMT) defined as a treatment change within prior 3-months unless due to intolerability.
  6. Current treatment with immunosuppressive or immunomodulatory therapy other than those approved for the treatment of MS.
  7. Any treatment with drugs known or suspected of producing retinal or optic nerve toxicity including hydroxychloroquine, chloroquine, clofazimine, vigabatrin, or ethambutol.
  8. Any history of ophthalmological cause for retinal damage other than MS (e.g. cataracts, uveitis, macular degeneration, macular exudate, macular edema, glaucoma, severe astigmatism, ocular trauma, neuromyelitis optica, ischemic optic neuropathy, congenital nystagmus, retinal detachment, amblyopia, optic disk drusen).
  9. Severe refractive defects: refractive errors (-6 dioptres to +6 dioptres or more in either eye, or axial eye length >26 mm), hypermetropia (> 6 dioptres; cylinder > 3 dioptres); or based on the investigators judgment any other ophthalmic diseases that would confound the study results or assessment of Visual Evoked Potential (VEPs), Best Corrected Visual Acuity (BCVA), Low Contrast Letter Acuity (LCLA), or Optical Coherence Tomography (OCT).
  10. History diabetic 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).
  11. History of human immunodeficiency virus (HIV), hepatitis C (HepC) virus antibody, or hepatitis B (HepB) virus antibody.
  12. History of gold allergy.
  13. Patients taking stimulant medications (including: amphetamine, dextroamphetamine, lisdexamfetamine, methylphenidate, or modafinil) who have not been on a stable dose greater than or equal to 30 days. Changes to dose will not be allowed during the course of the trial).
  14. Patients taking clemastine fumarate, 4-aminopyridine (fampridine), or high dose Biotin (>300 mg/day).
  15. Females who have a positive serum pregnancy test result at Screening or Baseline, or who are pregnant, breastfeeding, or planning to conceive during the study or within 180 days after study completion.
  16. History or evidence of substance abuse or alcohol abuse within 5 years prior to Screening, including alcoholism; or severe tobacco use (>1 pack/day).
  17. Clinical history of toxic neuropathy (e.g., secondary to treatment with ethambutol, isoniazid, linezolid, gentamycin, chloramphenicol, vincristine, or penicillamine).
  18. 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.
  19. Inability to undergo any planned study procedures such as LCLA, VEP, MRI, or OCT; history of severe hypersensitivity to gadolinium-DTPA or reduced renal clearance (GFR must be ≥ 45 mL/min at Screening), claustrophobia; or inability to comply with study requirements based on Investigator judgment.
  20. Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (< 150 x 10^9 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter) at Screening.
  21. 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, increase risk to the patient, or lead to difficulty complying with the protocol; including severe disc edema or hemorrhage, any clinically significant cardiac, endocrinological, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological (any progressive neurological disorder other than RRMS), dermatological, psychiatric (any untreated or unstable psychiatric disease including depression, bipolar and psychosis), renal, severe allergic or anaphylactic reactions, autoimmune, or other major confounding diseases.
  22. Any history of previous malignancy, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins.
  23. Patient is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.

Sites / Locations

  • UT Southwestern Medical Center
  • John Hunter Hospital
  • Sydney Brain Mind Centre
  • Princess Alexandria Hospital
  • Menzies Institute for Medical Research
  • Alfred Health
  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

15mg CNM-Au8

30mg CNM-Au8

Placebo

Arm Description

15mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water

30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water

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.

Outcomes

Primary Outcome Measures

Measures of Visual Function
Change in Best-Corrected Low-Contrast Letter Acuity (BC-LCLA) score: Mean change in BC-LCLA from Baseline to Week 48 in the most affected eye as measured by 2.5% low contrast Sloan letter charts.

Secondary Outcome Measures

Other Measures of Neurological Function
Change in the MS Functional Composite assessed by: Change from baseline for the average of the Z-scores of the six (m)MSFC domains. Combined ranked sum score for each (m)MSFC domain to the end of study. Time to the first repeated improvement of any two (m)MSFC domains by >=15%.

Full Information

First Posted
May 2, 2018
Last Updated
March 30, 2023
Sponsor
Clene Nanomedicine
Collaborators
Clene Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03536559
Brief Title
Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis
Acronym
VISIONARY-MS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 related enrollment challenges.
Study Start Date
November 23, 2018 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clene Nanomedicine
Collaborators
Clene Australia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed Description
This is a randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of CNM-Au8 in stable RRMS patients who have Chronic Optic Neuropathy evidence by low contrast letter acuity deficits at Screening. Patients will be screened over a 6-week period. Patients who meet the inclusion criteria and none of the exclusionary criteria will be enrolled into the clinical study. All enrolled patients will have their visual baseline established in both eyes by functional, electrophysiological (at participating research sites), and morphological tests. For each patient, the eye with the worst Baseline LCLA score will be considered as the affected eye. The other eye will be considered as the fellow eye. If both eyes have the same LCLA score at Baseline, then one eye will be randomly selected by the statistician to assess as the designated affected eye. Efficacy endpoints will be assessed in both the affected and the fellow eyes. Patients will be randomized to one of three groups: placebo, or one of two doses of CNM-Au8. All patients will receive their randomized investigational product (IP) dose daily over at least 24 consecutive weeks during the Fixed Duration Treatment Period. The study will also have a blinded Variable Duration Treatment Period for up to an additional 24-weeks (up to a 48-week maximum blinded duration) until the last-patient enrolled completes his/her Week 24 study visit per the study scheme in Figure 2. When the last enrolled patient completes his or her Week 24 visit, patients enrolled in the Variable Duration Treatment Period will complete the End-of-Study (EOS) visit at their next scheduled study visit. The primary efficacy outcome measure will be assessed Efficacy will be assessed as an improvement in best-corrected low contrast letter acuity (BC-LCLA). Safety will be assessed up through the frequency of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events (AEs), and changes in safety assessments (e.g., vitals, ECG, C-SSRS). The study will remain blinded until the study database is locked. All patients who are discontinued from treatment will complete the End-of-Study (EOS) assessment. At the end of the Variable Duration Treatment Period, patients will complete an EOS assessment and then may choose either to exit the study, or receive open-label CNM-Au8 in a separate Open-Label Safety Extension Study. An independent DSMB will be responsible for monitoring the safety of the study on a quarterly basis and ad hoc at the request of the DSMB or the Sponsor (e.g., in the event of unexpected SAEs) to review data throughout the Fixed Duration Treatment Period and the Variable Duration Treatment Period. The DSMB may make recommendations on the conduct of the study, including study termination. Appropriate procedures will be detailed in a DSMB Charter that will define disclosure of any findings along with patient- and study-stopping criteria. There will be four study periods: A six-week screening period (Screening Period); A fixed 24-week double-blind, randomized treatment period (Fixed Duration Treatment Period); A variable-duration, double-blind treatment period (Variable Duration Treatment Period) where patients continue the previously randomized treatment for up to an additional 24 weeks (total blinded duration of 48- weeks). This period will end for all patients when the last-enrolled patient reaches his or her 24-week visit (LP-24Wk) at which time patients in the Variable Duration Treatment Period will complete the EOS Visit at their next scheduled study visit; A four-week follow-up period (Safety Follow-Up Period) for patients not continuing in the separate Open-Label Long-Term Safety Extension Study. Following the end of the blinded treatment period, all patients who complete the 24-week Fixed Duration Treatment Period may be eligible to receive open-label CNM-Au8 in a separate Open-Label Long-Term Safety Extension Study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis, Optic Neuropathy, Optic; Neuritis, With Demyelination
Keywords
gold, nanocrystal, multifocal visual evoked potential, full field visual evoked potential, low contrast vision, low contrast letter acuity, remyelination, demyelination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, parallel group, placebo controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15mg CNM-Au8
Arm Type
Experimental
Arm Description
15mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water
Arm Title
30mg CNM-Au8
Arm Type
Experimental
Arm Description
30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CNM-Au8
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is liquid with identical color and taste
Primary Outcome Measure Information:
Title
Measures of Visual Function
Description
Change in Best-Corrected Low-Contrast Letter Acuity (BC-LCLA) score: Mean change in BC-LCLA from Baseline to Week 48 in the most affected eye as measured by 2.5% low contrast Sloan letter charts.
Time Frame
Baseline to 48 weeks
Secondary Outcome Measure Information:
Title
Other Measures of Neurological Function
Description
Change in the MS Functional Composite assessed by: Change from baseline for the average of the Z-scores of the six (m)MSFC domains. Combined ranked sum score for each (m)MSFC domain to the end of study. Time to the first repeated improvement of any two (m)MSFC domains by >=15%.
Time Frame
Baseline up to 48 weeks
Other Pre-specified Outcome Measures:
Title
Multifocal Visual Evoked Potential (mfVEP) Latency
Description
mfVEP latency is an electrophysiologic measure of remyelination that assesses the speed of conduction of electrical signals in neurons of the visual system.
Time Frame
Every 12 weeks following the 6-month primary endpoint, up to 48-weeks
Title
Multifocal Visual Evoked Potential (mfVEP) Amplitude
Description
mfVEP amplitude is an electrophysiologic measure of axonal protection that assesses the magnitude of electrical signals in neurons of the visual system.
Time Frame
Every 12 weeks following the 6-month primary endpoint, up to 48-weeks
Title
Full field Visual Evoked Potentials (ff-VEP) latency
Description
ffVEP latency is an electrophysiologic measure of remyelination that assesses the latency of electrical signals conduction in neurons of the visual system.
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
Full field Visual Evoked Potentials (ff-VEP) amplitude
Description
ffVEP amplitude is an electrophysiologic measure of axonal protection that assesses the magnitude of electrical signals in neurons of the visual system.
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
Optical Coherence Tomography (OCT)
Description
Measure of optic nerve morphology and retinal layers
Time Frame
At three month intervals beginning at 24-weeks, up to 48-weeks
Title
Magnetic Resonance Imaging (MRI)
Description
Structural imaging of MS lesions
Time Frame
At three month intervals beginning at 24-weeks, up to 48-weeks
Title
Change in Best High Contrast Visual Acuity Testing (HCVA)
Description
Mean change from Baseline in best-corrected high contrast visual acuity (BC-HCVA) score, as measured by EDTRS in the affected and fellow eye.
Time Frame
Every 6-weeks, up to 48-weeks
Title
Expanded Disability Status Scale (EDSS)
Description
Standardized MS functional scales
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
9-Hole Peg Test
Description
Standardized test of upper body extremity function
Time Frame
Every 12-weeks, up to 48-weeks
Title
Symbol Digit Modality Test (SDMT)
Description
Pattern matching functional scale
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
Description
Visual Function Quality of Life Scales
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
Ten-item Neuro-Ophthalmic Supplement (10-item NOS)
Description
Visual Function Quality of Life Scales
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
Six-Minute Walk Test (6MWT)
Description
Standardized Measure of Mobility and Exercise Tolerance
Time Frame
At three month intervals beginning at 12-weeks, up to 48-weeks
Title
Timed 25-Foot Walk Test
Description
Quantitative mobility and leg function performance test
Time Frame
Every 12-weeks, up to 48-weeks
Title
Individual OR Lesion MRI Analysis
Description
Mean change in optic radiation lesional/non-lesional fibre DTI Divided by the MTR difference from Baseline.
Time Frame
Week 24 and week 48.
Title
Myelin Water Fraction MRI Analysis
Description
Myelin Water Fraction (MWF) will be assessed with mcDESPOT imaging
Time Frame
Week 24 and Week 48
Title
Whole Brian Diffusion Tensor Imaging (DTI) divided by Magnetization Transfer Ratio (MTR)
Description
Mean change in whole brain DTI / MTR from Baseline.
Time Frame
Week 24 and week 48
Title
Whole Brian White Matter Diffusion Tensor Imaging (DTI) divided by Magnetization Transfer Ratio (MTR)
Description
Mean change in whole brain white matter DTI / MTR from Baseline.
Time Frame
Week 24 and week 48
Title
Whole Brian Lesion Diffusion Tensor Imaging (DTI) divided by Magnetization Transfer Ratio (MTR)
Description
Mean change in whole brain lesion DTI / MTR from Baseline.
Time Frame
Week 24 and week 48
Title
Optic Radiation Diffusion Tensor Imaging (DTI) divided by Magnetization Transfer Ratio (MTR)
Description
Mean change in optic radiation DTI / MTR from Baseline.
Time Frame
Week 24 and week 48
Title
Optic Radiation Lesion Diffusion Tensor Imaging (DTI) divided by Magnetization Transfer Ratio (MTR)
Description
Mean change in optic lesion radiation DTI / MTR from Baseline.
Time Frame
Week 24 and week 48
Title
Change in Best Corrected Low-Contrast Letter Acuity (BC-LCLA)
Description
Mean change by eye from Baseline in BC-LCLA score as determined by 2.5% low contrast Sloan letter chart for the affected and fellow eye. Proportion of patients with an improvement of at least 7 character letters by 2.5% low contrast Sloan letter chart in the affected and fellow eye.
Time Frame
Baseline up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. a. BC-HCVA is defined as the last line on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart that a patient is able to read three (3) or more letters correctly. 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. a. BC-LCLA is defined as the last line on the 2.5% Sloan Chart that a patient is able to read three (3) or more letters correctly. 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: History of AQP4, MOG Ab(+) status, or ≥ 3 segments lesion in the spinal cord. Any diagnosis other than RMS that could explain the patient's signs and symptoms. An acute optic neuritis episode within the prior 6 months. Clinical relapse requiring systemic steroid treatment within the prior 3 months (pre- treatment with systemic steroids during the administration of disease-modifying therapies [DMT] may be allowed after discussion with the Sponsor's Medical Monitor but must not be administered within 30 days of a planned VEP or MRI assessment). Unstable treatment with a disease-modifying therapy (DMT) defined as a treatment change within prior 3-months unless due to intolerability. Current treatment with immunosuppressive or immunomodulatory therapy other than those approved for the treatment of MS. Any treatment with drugs known or suspected of producing retinal or optic nerve toxicity including hydroxychloroquine, chloroquine, clofazimine, vigabatrin, or ethambutol. Any history of ophthalmological cause for retinal damage other than MS (e.g. cataracts, uveitis, macular degeneration, macular exudate, macular edema, glaucoma, severe astigmatism, ocular trauma, neuromyelitis optica, ischemic optic neuropathy, congenital nystagmus, retinal detachment, amblyopia, optic disk drusen). Severe refractive defects: refractive errors (-6 dioptres to +6 dioptres or more in either eye, or axial eye length >26 mm), hypermetropia (> 6 dioptres; cylinder > 3 dioptres); or based on the investigators judgment any other ophthalmic diseases that would confound the study results or assessment of Visual Evoked Potential (VEPs), Best Corrected Visual Acuity (BCVA), Low Contrast Letter Acuity (LCLA), or Optical Coherence Tomography (OCT). History diabetic 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). History of human immunodeficiency virus (HIV), hepatitis C (HepC) virus antibody, or hepatitis B (HepB) virus antibody. History of gold allergy. Patients taking stimulant medications (including: amphetamine, dextroamphetamine, lisdexamfetamine, methylphenidate, or modafinil) who have not been on a stable dose greater than or equal to 30 days. Changes to dose will not be allowed during the course of the trial). Patients taking clemastine fumarate, 4-aminopyridine (fampridine), or high dose Biotin (>300 mg/day). Females who have a positive serum pregnancy test result at Screening or Baseline, or who are pregnant, breastfeeding, or planning to conceive during the study or within 180 days after study completion. History or evidence of substance abuse or alcohol abuse within 5 years prior to Screening, including alcoholism; or severe tobacco use (>1 pack/day). Clinical history of toxic neuropathy (e.g., secondary to treatment with ethambutol, isoniazid, linezolid, gentamycin, chloramphenicol, vincristine, or penicillamine). 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. Inability to undergo any planned study procedures such as LCLA, VEP, MRI, or OCT; history of severe hypersensitivity to gadolinium-DTPA or reduced renal clearance (GFR must be ≥ 45 mL/min at Screening), claustrophobia; or inability to comply with study requirements based on Investigator judgment. Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (< 150 x 10^9 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter) at Screening. 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, increase risk to the patient, or lead to difficulty complying with the protocol; including severe disc edema or hemorrhage, any clinically significant cardiac, endocrinological, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological (any progressive neurological disorder other than RRMS), dermatological, psychiatric (any untreated or unstable psychiatric disease including depression, bipolar and psychosis), renal, severe allergic or anaphylactic reactions, autoimmune, or other major confounding diseases. Any history of previous malignancy, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins. Patient is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Beadnall, MD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Sydney Brain Mind Centre
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Princess Alexandria Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Menzies Institute for Medical Research
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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