Overview

Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects. Neurological assessment including the determination of the Expanded Disability Status Scale (EDSS) score and ophthalmologic evaluations were performed every 3 months and during relapses. Flow cytometric analysis, brain and spinal cord MRI was performed at baseline, 6, 12, 18, and 24 months.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xuanwu Hospital, Beijing
Treatments:
Mitoxantrone
Criteria
Inclusion Criteria:

- Recurrent longitudinal myelitis (>3 segments of spinal cord involvement by MRI) with
or without recurrent ON (unilateral or bilateral) but with normal brain MRI and
positive serological NMO IgG antibody.

- Recurrent longitudinal myelitis (>3 segments of spinal cord involvement by MRI) with
or without spatially limited brain lesion and positive serological NMO IgG antibody.

- NMO, fulfilled Wingerchuk 2006 Criteria for NMO.

- Patient presented at least 2 relapses during the 12 months preceding the start of
mitoxantrone therapy, despite immunotherapies using corticosteroid, interferon beta,
azathioprine, cyclophosphamide, Cyclosporin A, Mycophenolate Mofetil or a combination
of these drugs

- Extended Disability Status Score 3-8.

- Normal range for white-blood-cell count (more than 4×109/L), neutrophil count (more
than 2×109/L), and platelet count (more than 100×109/L).

Exclusion Criteria:

- Cardiac risk factors (e.g history of congestive heart failure and left ventricular
ejection fraction (LVEF) < 50%

- Systemic diseases such as lupus, Sjogren's syndrome, anti-phospholipid antibody
syndrome, sarcoidosis, rheumatoid arthritis, or vitamin B12 deficiency

- Previous treatment with mitoxantrone or anthracyclines

- Pregnant or planning to be pregnant

- Patients with severe liver disorders (WHO grade 4)