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Sponsors and Collaborators: |
State University of New York at Buffalo EMD Serono |
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Information provided by: | State University of New York at Buffalo |
ClinicalTrials.gov Identifier: | NCT00304291 |
Neuromyelitis optica (NMO) is a severe demyelinating disease that selectively involves the optic nerves and the spinal cord but usually spares the brain. NMO is considered to have a B cell induced pathogenesis. Mitoxantrone (MITO, Novantrone®), a synthetic anthracenedione approved for worsening relapsing-remitting multiple sclerosis (MS) and secondary progressive MS, has been shown to primarily suppress the humoral response. We conducted a prospective 2-year study to evaluate the benefit of MITO in five relapsing NMO patients.
Condition | Intervention | Phase |
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Neuromyelitis Optica Myelitis, Transverse Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Drug: Mitoxantrone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease) |
Estimated Enrollment: | 5 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | May 2004 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Baird Multiple Sclerosis Center | |
Buffalo, New York, United States, 14203 |
Study Director: | Bianca Weinstock-Guttman, M.D. | Baird Multiple Sclerosis Center |
Study ID Numbers: | JNI-NMO-101 |
Study First Received: | March 15, 2006 |
Last Updated: | November 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00304291 |
Health Authority: | United States: Food and Drug Administration |
Novantrone |
Papillitis Spinal Cord Diseases Neuromyelitis Optica Demyelinating diseases Neurodegenerative Diseases Neuritis Multiple Sclerosis Myelitis, Transverse Autoimmune Diseases of the Nervous System Nervous System Neoplasms Optic Neuritis Autoimmune Diseases Devic disease Demyelinating Diseases |
Eye Diseases Central Nervous System Diseases Sclerosis Optic nerve disorder Recurrence Virus Diseases Paraneoplastic Syndromes Central Nervous System Infections Demyelinating Autoimmune Diseases, CNS Myelitis Optic Nerve Diseases Mitoxantrone Paraneoplastic Syndromes, Nervous System |
Immune System Diseases Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Central Nervous System Viral Diseases Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Therapeutic Uses Cranial Nerve Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents |