Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | March 15, 2006 | ||||
Last Updated Date | November 27, 2006 | ||||
Start Date † | August 2001 | ||||
Current Primary Outcome Measures † |
Relapse rate | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00304291 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Safety | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease) | ||||
Official Title † | A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease) | ||||
Brief 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. |
||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
|
||||
Intervention † | Drug: Mitoxantrone | ||||
Study Arms / Comparison Groups | |||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 5 | ||||
Completion Date | May 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00304291 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | State University of New York at Buffalo | ||||
Collaborators †† | EMD Serono | ||||
Investigators † |
|
||||
Information Provided By | State University of New York at Buffalo | ||||
Verification Date | March 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |