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A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)

Phase 4
18 Years
55 Years
Not Enrolling
Neuromyelitis Optica, Myelitis, Transverse, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System

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Trial Information

A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)

The treatment protocol consisted of monthly 12 mg/m2 MITO intravenous infusions for 6 months
followed by 3 additional treatments every 3 months. Neurological assessment including the
determination of the Expanded Disability Status Scale (EDSS) score was performed every 3
months and during relapses. Orbital, brain and spinal cord MRI was performed at baseline,
3, 6, 12, 18, and 24 months. Visual evoked potentials and ophthalmologic evaluations were
performed at baseline and annually.

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.

- Patients with recurrent longitudinally extensive myelitis without optic neuritis have
an underlying pathology and serology similar to NMO and it is appropriate to consider
this a form of NMO10.

- Cerebrospinal fluid required no intrathecal IgG synthesis or oligoclonal bands.

- Age was required to be 18-55 years

- Extended Disability Status Score ≤ 7.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse rate

Principal Investigator

Bianca Weinstock-Guttman, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Baird Multiple Sclerosis Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2001

Completion Date:

May 2004

Related Keywords:

  • Neuromyelitis Optica
  • Myelitis, Transverse
  • Demyelinating Autoimmune Diseases, CNS
  • Autoimmune Diseases of the Nervous System
  • Novantrone
  • Autoimmune Diseases
  • Myelitis
  • Myelitis, Transverse
  • Nervous System Diseases
  • Neuromyelitis Optica
  • Autoimmune Diseases of the Nervous System
  • Demyelinating Autoimmune Diseases, CNS



Baird Multiple Sclerosis CenterBuffalo, New York  14203