Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Funding Agency | Other Grant/Funding Number | Neuroscience Canada |
Not provided
Not provided
Lack of recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Neuroscience Canada | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | 100mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luanne Metz, Dr. | University of Calgary | Principal Investigator |
| Fiona Costello, Dr. | University of Calgary | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009902 | Optic Neuritis |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |