Multiple SclerosisPhase 2Mino in ONNCT01073813
Neuroprotection and Repair in Optic Neuritis
A Phase 2 study testing Minocycline in people with Multiple Sclerosis and Optic Neuritis, run by University of Calgary.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Optic Neuritis
- What is being tested?
- Minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Optic Neuritis
- Being tested
- Minocycline
- Keywords
- Minocycline, Retinal nerve fibre layer thickness, Macular volume, Visual outcomes
- Medical subject headings
- Multiple Sclerosis, Optic Neuritis, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
100mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and every three months for nine months
Secondary outcomes (1)
Other functional and structural optic nerve recovery measures
Secondary outcomes are temporal RNFL thickness, macular volume, and visual outcomes.
Measured: At baseline and every three months for nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionJan 2013
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroscience Canada
- Responsible party
- Principal investigator, Dr. Luanne Metz, University of Calgary
- Investigators
- Luanne Metz, Dr., Principal investigator, University of CalgaryFiona Costello, Dr., Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073813
- Sponsor's protocol ID
- Minocycline in Optic Neuritis
- Other IDs
- Funding Agency
- Acronym
- Mino in ON
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Neuroprotection and Repair Strategies in MS: Phase IIa Randomized, Controlled Trial of Minocycline in Acute Optic Neuritis (ON)
- ClinicalTrials.gov ID
- NCT01073813
- Acronym / sponsor ID
- Mino in ON / Minocycline in Optic Neuritis
- Conditions
- Multiple Sclerosis, Optic Neuritis
- Keywords
- Minocycline, Retinal nerve fibre layer thickness, Macular volume, Visual outcomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Neuroscience Canada
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline 100mg | Active comparator | Drug: MinocyclinePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline100mg twice daily | Drug | Minocycline 100mg |
Primary outcome
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.
1 secondary outcome
Other functional and structural optic nerve recovery measures
Time frame: At baseline and every three months for nine months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luanne Metz, Dr. principal investigator
University of Calgary
Fiona Costello, Dr. principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Multiple Sclerosis and Optic Neuritis, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fibre layer (time frame: At baseline and every three months for nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.