Trial record 2 of 22 for:    "neuromyelitis optica" OR "Neuromyelitis Optica"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Xuanwu Hospital, Beijing
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT02021825
First received: September 3, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorders
Drug: Mitoxantrone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Xuanwu Hospital, Beijing:

Primary Outcome Measures:
  • annual relapse rate (ARR) [ Time Frame: one year ] [ Designated as safety issue: No ]
    ARR is defined as the number of confirmed relapses in a year. The number of annual relapse rate was used as parameters of effectiveness and was compared between premitoxantrone and postmitoxantrone treatment during the follow-up period.

  • EDSS [ Time Frame: six months ] [ Designated as safety issue: No ]
    Expanded Disability Status Scale (EDSS) scores was used as parameters of effectiveness and was compared between premitoxantrone and postmitoxantrone treatment during the follow-up period.


Secondary Outcome Measures:
  • Changes in LVEF [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    - Assessment of cardiac function: Changes in LVEF by transthoracic echocardiography and determination of cardiac side effects by ECG and by measurement of CK-MB, Troponin and BNP.

  • blood cell count [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    - Assessment of hematological system: Monitoring blood cell count regularly. Considering marrow puncture if necessary.

  • Flow cytometric analysis [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Immunofluorescent staining of wholeblood samples were performed of blood drawing using antibodies against CD3/CD4/CD8/CD19/CD20/CD56 with isotype controls, followed by lysis of red blood cells and immediate acquisition and analysis by flow cytometry.


Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MITO, annual relapse rate, safety
For refractory NMO patients aged 18-55, the initial dose 12 mg/m2 mitoxantrone was administered over a five day course every 3 months for 2 years (a total of eight courses). The initial dose was reduced to 9 mg/m2 if the preinfusion white-blood-cell count was 3.0-3.99 ×109/L,and to 6 mg/m2 if the white-blood-cell count was 2.0-2.99 ×109/L. No infusion if the white-blood-cell count was less than 2.0×109/L. The initial dose was reduced to 10 mg/m2 for nonhaematological toxic effects of WHO grade 2-3. Subsequent dose after 3 month was reduced to 10 mg/m2 for infections that occurred within 3 weeks of a previous infusion accompanied by a white-blood-cell count below 2×109/L, or to 8 mg/m2 for infections accompanied by white-blood-cell count of less than 1×109/L.
Drug: Mitoxantrone
The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects.
Other Name: Novantrone

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021825

Contacts
Contact: Huiqing Dong, Doctor +86-18611786966 shshtt@sina.com‍
Contact: Zheng Liu, Doctor +86-13910320552 lzwcy2003@aliyun.com

Locations
China, Beijing
Department of Neurology, Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Zheng Liu, Doctor    0086-13910320552    lzwcy2003@aliyun.com   
Principal Investigator: Huiqing Dong, Doctor         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Principal Investigator: Huiqing Dong, Doctor Department of Neurology, Xuanwu Hospital, Capital Medical University
  More Information

Publications:
Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02021825     History of Changes
Other Study ID Numbers: MITONMO
Study First Received: September 3, 2013
Last Updated: December 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xuanwu Hospital, Beijing:
mitoxantrone
neuromyelitis optica
relapse

Additional relevant MeSH terms:
Neuromyelitis Optica
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Mitoxantrone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014