Neuroprotection and Repair in Optic Neuritis (Mino in ON)

January 21, 2013 updated by: Dr. Luanne Metz, University of Calgary

Developing Neuroprotection and Repair Strategies in MS: Phase IIa Randomized, Controlled Trial of Minocycline in Acute Optic Neuritis (ON)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal nerve fibre layer
Time Frame: At baseline and every three months for nine months
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.
At baseline and every three months for nine months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other functional and structural optic nerve recovery measures
Time Frame: At baseline and every three months for nine months
Secondary outcomes are temporal RNFL thickness, macular volume, and visual outcomes.
At baseline and every three months for nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Neuroscience Canada

Investigators

  • Principal Investigator: Luanne Metz, Dr., University of Calgary
  • Principal Investigator: Fiona Costello, Dr., University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minocycline in Optic Neuritis
  • Funding Agency (Other Grant/Funding Number: Neuroscience Canada)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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