Trials / Completed
CompletedNCT00304291
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 5 (planned)
- Sponsor
- State University of New York at Buffalo · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Neuromyelitis Optica
- Myelitis, Transverse
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mitoxantrone |
Timeline
- Start date
- 2001-08-01
- Completion
- 2004-05-01
- First posted
- 2006-03-17
- Last updated
- 2020-12-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00304291. Inclusion in this directory is not an endorsement.