Neuroprotection and Repair in Optic Neuritis

NCT01073813 | Terminated Phase 2

• 2 other identifiers: Minocycline in Optic NeuritisFunding Agency
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Sclerosis; Optic Neuritis

Keywords

Minocycline; Retinal nerve fibre layer thickness; Macular volume; Visual outcomes

Outcome Measures

Primary Outcomes (1)

• Retinal nerve fibre layer

  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 Outcomes (1)

• Other functional and structural optic nerve recovery measures

  At baseline and every three months for nine months

Study Arms (2)

Minocycline 100mg

ACTIVE COMPARATOR

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

No treatment

NO INTERVENTION

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.

Interventions

Minocycline DRUG

100mg twice daily

Minocycline 100mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Neuroscience Canada: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Optic Neuritis; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Luanne Metz, Dr.

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Fiona Costello, Dr.

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2013
• Last Updated: January 23, 2013

Record last verified: 2013-01