Clinical Trials

A phase 2 study to evaluate the effect of small gold particles on healing eyesight in patients with Relapsing-Remitting Multiple Sclerosis

Type of Study/Intervention

Drug

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS

Brief summary

Full trial title

VISIONARY-MS: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled 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 Stable Relapsing-Remitting Multiple Sclerosis (RRMS)

Summary

The objective of this trial is to assess the efficacy and safety of the study drug CNMAu8 as a remyelinating treatment for vision-impairing MS lesions in participants who have RRMS. The primary endpoint is the change in remyelination measured after 24 weeks of treatment.

The trial will be conducted in up to 10 centres across Australia, New Zealand, Canada and the United States, with Australia being the main recruiting country. It is estimated the blinded study period will be approximately 52 weeks. Approximately 150 patients will be randomized in a ratio of 1:1:1 to receive either one of two doses of study drug or a matched placebo. Subjects will take a single oral dose daily and be on treatment for a minimum of 24 weeks and up to a maximum of 48 weeks, Subjects will be 18 to 50 years of age and have given informed consent prior to any study assessments and treatment. Subjects must be able to undergo planned procedures and may need to be at study centres from 1 to 6 hours.

Inclusion criteria

  • At least 18 years of age and up to 50 years (inclusive) of age at Baseline.
  • Clinical diagnosis of Multiple Sclerosis (MS) (meeting McDonald criteria, 2010) who have had RRMS no longer than 10 years from diagnosis.
  • Presence of chronic optic neuropathy defined by one of the following clinical and/or multifocal visual evoked potential (mf-VEP) criteria:
  • Patients with a clinical history of unilateral optic neuritis more than 6 months prior to Screening without current active disease in the affected eye:

–             Mean mf-VEP latency asymmetry between the affected and fellow eye of at least 8 ms;

AND

–             Documented unilateral optic neuritis by clinical history for the presence of at least two of the following: reduced visual acuity, afferent pupillary defect, colour vision loss, visual field abnormality, or pain on eye movement.

  • Patients without a clinical history of unilateral optic neuritis must have a documented mf-VEP latency abnormality, including either:

–             Mean mf-VEP latency of at least 153 ms in one eye AND asymmetry between the affected and fellow eye of at least 8 ms;

OR

–             Mean mf-VEP latency of at least 153 ms in both eyes.

  • At Screening, patients must have measurable mf-VEP latency values in at least:
  • 50% of the field of the measurable mf-VEP segments in the affected eye in patients with unilateral chronic optic neuropathy, OR
  • 50% of the field of the measurable mf-VEP segments in both eyes in patients with bilateral chronic optic neuropathy.
  • Best Corrected High Contrast Visual Acuity (BC-HCVA) by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart with a score of at least 20/200 (maximum deficit) in both eyes, but not better than 20/30 (minimum deficit) in the affected eye (or both eyes).
  • Best Corrected Low Contrast Letter Acuity (BC-LCLA) (by 2.5% Sloan Chart) score at least 20/200 or better (maximum deficit) in both eyes.
  • Mean Retinal Nerve Fiber Layer (RNFL) thickness ≥ 70μm.
  • Stable disease activity based on the Investigator’s judgment over the prior 12 months.
  • Able to understand and give written informed consent.

Exclusion criteria

  • An acute optic neuritis episode or systemic steroid treatment within the prior 6 months.
  • Clinical relapse requiring systemic steroid treatment within the prior 12 months.
  • Unstable treatment with a disease modifying therapy (DMT) defined as a treatment change within the prior 3-months unless due to intolerability.
  • Any immunosuppression therapy other than those approved for the treatment of MS.
  • Any drug known or suspected of producing retinal or optic nerve toxicity including hydroxychloroquine, chloroquine, clofazimine, vigabatrin, or ethambutol.
  • Any active 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 (> 5 dioptres; cylinder > 3 dioptres); or based on the investigator’s judgment any other ophthalmic diseases that would confound the study results or assessment of VEPs, high contrast Best Corrected Visual Acuity (BCVA), Low Contrast Letter Acuity (LCLA), or Optical Coherence Tomography (OCT).
  • A diagnosis of Diabetes Mellitus or 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).
  • Patients taking clemastine fumarate or 4-aminopyridine (fampridine).
  • Females who have a positive serum pregnancy test result at Baseline, or who are pregnant, breastfeeding, or planning to conceive during the study.
  • 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 penicilamine).
  • Current enrollment in any other drug or device treatment study within 3-months prior to Baseline. Current 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 VEP or magnetic resonance imaging (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.
  • 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, history of previous malignancy within 3 years of the Screening Visit (or within 1 year of the Screening Visit if basal cell or squamous cell carcinoma of the skin), or other major confounding disease.

Anticipated start date

July 2018

Recruitment status

Pending

Recruitment contacts

NSW:

Marinda Taha: [email protected]

T +61 2 9351 0704

Clinical Trials Manager, MS Clinical Trials, Brain & Mind Centre, THE UNIVERSITY OF SYDNEY

VIC:

Belinda Bardsley: [email protected]

T +613 9496 3705

N-CRESS Manager, Austin Health,

and

Pushpa Richards: [email protected]

Administrative Assistant, MS Clinical and Research Unit, Royal Melbourne Hospital

T +61 3 9342 9092

QLD:

Wendy Ockendon: [email protected]

T +61 7 3176 9459

MS Nurse/Research Co-ordinator Princess Alexandra Hospital

WA:

Susan Walters: [email protected]

T +61 8 6457 0209

Clinic Manager/Clinical Trials Co-ordinator, Perron Institute for Neurological and Translational Science

Further details

For further details visit here:

Region

NSW/VIC/QLD/WA

Trial number

NCT03536559

Ethics Approval

Yes

Last updated

14/1//2018

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