Neuroprotection and Repair in Optic Neuritis
Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis; Optic Neuritis
Intervention: Minocycline (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: University of Calgary Official(s) and/or principal investigator(s): Luanne Metz, Dr., Principal Investigator, Affiliation: University of Calgary Fiona Costello, Dr., Principal Investigator, Affiliation: University of Calgary
Summary
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.
Clinical Details
Official title: Developing Neuroprotection and Repair Strategies in MS: Phase IIa Randomized, Controlled Trial of Minocycline in Acute Optic Neuritis (ON)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Retinal nerve fibre layer
Secondary outcome: Other functional and structural optic nerve recovery measures
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: February 2010
Last updated: January 21, 2013
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