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

Information source: Xuanwu Hospital, Beijing
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorders

Intervention: Mitoxantrone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Xuanwu Hospital, Beijing

Official(s) and/or principal investigator(s):
Huiqing Dong, Doctor, Principal Investigator, Affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University

Overall contact:
Huiqing Dong, Doctor, Phone: +86-18611786966, Email: shshtt@sina.com‍

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

annual relapse rate (ARR)

EDSS

Secondary outcome:

Changes in LVEF

blood cell count

Flow cytometric analysis

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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)

Locations and Contacts

Huiqing Dong, Doctor, Phone: +86-18611786966, Email: shshtt@sina.com‍

Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053, China; Recruiting
Zheng Liu, Doctor, Phone: 0086-13910320552, Email: lzwcy2003@aliyun.com
Huiqing Dong, Doctor, Principal Investigator
Additional Information

Related publications:

Hartung HP, Gonsette R, König N, Kwiecinski H, Guseo A, Morrissey SP, Krapf H, Zwingers T; Mitoxantrone in Multiple Sclerosis Study Group (MIMS). Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet. 2002 Dec 21-28;360(9350):2018-25.

Neuhaus O, Kieseier BC, Hartung HP. Therapeutic role of mitoxantrone in multiple sclerosis. Pharmacol Ther. 2006 Jan;109(1-2):198-209. Epub 2005 Aug 10. Review.

Kim SH, Kim W, Park MS, Sohn EH, Li XF, Kim HJ. Efficacy and safety of mitoxantrone in patients with highly relapsing neuromyelitis optica. Arch Neurol. 2011 Apr;68(4):473-9. doi: 10.1001/archneurol.2010.322. Epub 2010 Dec 13.

Weinstock-Guttman B, Ramanathan M, Lincoff N, Napoli SQ, Sharma J, Feichter J, Bakshi R. Study of mitoxantrone for the treatment of recurrent neuromyelitis optica (Devic disease). Arch Neurol. 2006 Jul;63(7):957-63.

Starting date: March 2009
Last updated: December 19, 2013

Page last updated: August 23, 2015

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