Neuroprotection and Repair in Optic Neuritis

Multiple Sclerosis Clinical Trial

— Mino in ON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01073813
• Other study ID #: Minocycline in Optic Neuritis
• Secondary ID: Funding Agency
• Status: Terminated
• Phase: Phase 2
• First received: February 22, 2010
• Last updated: January 21, 2013
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuritis
• Optic Neuritis

Intervention

Drug:
• Minocycline
100mg twice daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Neuroscience Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Other functional and structural optic nerve recovery measures	Secondary outcomes are temporal RNFL thickness, macular volume, and visual outcomes.	At baseline and every three months for nine months	No