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This is a multicenter, randomized, double-blind, placebo-controlled Phase â…¡ study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with different doses in participants with neuromyelitis optica spectrum disorder (NMOSD). Participants will be randomly enrolled into three groups: Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group, Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group, and Placebo group. The primary outcome measure is time to first protocol-defined relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group | Experimental |
| |
| Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group | Experimental |
| |
| Placebo Injection every 12 weeks (Q12W). | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection | Drug | IV, once every 12 weeks (Q12W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Protocol-defined Relapse | Time to First Protocol-defined Relapse was defined as time from randomization to first occurrence of relapse. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neuromyelitis optica spectrum disorder (NMOSD). | Up to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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