Neuroprotection and Repair in Optic Neuritis (Mino in ON)

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborator:
Neuroscience Canada
Information provided by (Responsible Party):
Dr. Luanne Metz, University of Calgary
ClinicalTrials.gov Identifier:
NCT01073813
First received: February 22, 2010
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

The primary aim of this open-label pilot trial is to estimate the treatment effect of 100 mg of oral minocycline twice daily for 90 days, initiated within 30 days of onset of ON, on functional and structural optic nerve recovery compared to no treatment. The primary outcome measure that will be used to measure optic nerve recovery is retinal nerve fibre layer (RNFL) thickness. Other objectives: Secondary outcomes are temporal RNFL thickness, macular volume, and visual outcomes.


Condition Intervention Phase
Multiple Sclerosis
Optic Neuritis
Drug: Minocycline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Developing Neuroprotection and Repair Strategies in MS: Phase IIa Randomized, Controlled Trial of Minocycline in Acute Optic Neuritis (ON)

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Retinal nerve fibre layer [ Time Frame: At baseline and every three months for nine months ] [ Designated as safety issue: No ]
    The primary aim of this open-label pilot trial is to estimate the treatment effect of 100 mg of oral minocycline twice daily for 90 days, initiated within 30 days of onset of ON, on functional and structural optic nerve recovery compared to no treatment. The primary outcome measure that will be used to measure optic nerve recovery is RNFL thickness.


Secondary Outcome Measures:
  • Other functional and structural optic nerve recovery measures [ Time Frame: At baseline and every three months for nine months ] [ Designated as safety issue: No ]
    Secondary outcomes are temporal RNFL thickness, macular volume, and visual outcomes.


Enrollment: 6
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minocycline 100mg
Patients are in one of three strata (currently on Glatiramer acetate (GA), Interferon beta (IFN), or neither disease modifying therapy (DMT). There will be a minimum of 12 patients per strata. Patients will be randomized within each strata in a 2:1 fashion to receive either Minocycline 100mg twice daily or no treatment.
Drug: Minocycline
100mg twice daily
No Intervention: No treatment
Patients are in one of three strata (currently on Glatiramer acetate (GA), Interferon beta (IFN), or neither disease modifying therapy (DMT). There will be a minimum of 12 patients per strata. Patients will be randomized within each strata in a 2:1 fashion to receive either Minocycline 100mg twice daily or no treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 60 years, the lower age limit has been set for safety purposes to avoid exposing children and adolescents to unproven therapies at least early in their development, the upper limit is set because the specificity of the diagnosis of ON is likely reduced in older individuals
  • onset of ON within the previous 30 days
  • intention to continue current multiple sclerosis (MS) disease modifying therapy (if any) for at least 6 months (glatiramer acetate, interferon beta) and not start, or switch to, a new therapy
  • sexually active participants of child-bearing potential must agree to use adequate contraception
  • willingness to provide written informed consent

Exclusion Criteria:

  • Coexistence of any disease other than MS that could be responsible for ON or better explains their signs and symptoms. This would include patients with other suspected or established causes of vision loss including glaucoma, maculopathies, amblyopia, neuro-myelitis optica (NMO), and other optic neuropathies
  • clinically significant liver, renal, or bone marrow dysfunction
  • any condition that could interfere with any evaluation in the study including patients who are unable to undergo reliable OCT testing due to dense media opacities or severe nystagmus in whom appropriate fixation cannot be attained
  • concurrent or prior use of corticosteroids during this episode of optic neuritis
  • concurrent participation in any clinical therapeutic trial
  • use within the previous 12 months of any of the following: natalizumab, mitoxantrone, cyclophosphamide, azathioprine, cyclosporine, methotrexate, or any other immunomodulating or immunosuppressive drug including other recombinant or non-recombinant cytokine or any experimental therapy known to effect immune function
  • use within the previous 6 months of minocycline or another tetracycline or use of either for MS at any time
  • any other condition or situation that in the opinion of the investigator would either put the patient at risk of worsening health if enrolled in the trial or would prevent completion of the trial with complete follow-up.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01073813

Sponsors and Collaborators
University of Calgary
Neuroscience Canada
Investigators
Principal Investigator: Luanne Metz, Dr. University of Calgary
Principal Investigator: Fiona Costello, Dr. University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Luanne Metz, Neurologist, University of Calgary
ClinicalTrials.gov Identifier: NCT01073813     History of Changes
Other Study ID Numbers: Minocycline in Optic Neuritis, Funding Agency
Study First Received: February 22, 2010
Last Updated: January 21, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Minocycline
Retinal nerve fibre layer thickness
Macular volume
Visual outcomes

Additional relevant MeSH terms:
Optic Neuritis
Multiple Sclerosis
Neuritis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Cranial Nerve Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Eye Diseases
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Peripheral Nervous System Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014