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NCT00304291 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Neuromyelitis Optica and Myelitis, Transverse, sponsored by State University of New York at Buffalo.

Completed
Registry status
Phase 4
Development phase
5
Enrollment target
1
Study location

NCT00304291: Completed Phase 4 study of Neuromyelitis Optica and Myelitis, Transverse, sponsored by State University of New York at Buffalo.

NCT00304291 is a Phase 4 study of Neuromyelitis Optica and Myelitis, Transverse that has completed, run by State University of New York at Buffalo. The registered enrollment target is 5 participants, below the 513-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00304291, a Phase 4 study of Neuromyelitis Optica and Myelitis, Transverse, has completed, sponsored by State University of New York at Buffalo.

COMPLETED
Registry status
Phase 4
Development phase
5 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Mitoxantrone

Study Locations (1)

New York

  • Baird Multiple Sclerosis Center - Buffalo

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2001-08
Est. Completion 2004-05
Phase Phase 4

What the finished NCT00304291 record still lists

NCT00304291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 513-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (99% lower).

The record links to 4 conditions, with Neuromyelitis Optica appearing as the primary indexed condition, and to 1 intervention - of which Mitoxantrone is the first listed.

NCT00304291 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00304291 about?

NCT00304291 is a clinical study titled "A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)". 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 rela...

What is the current status of trial NCT00304291?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2001-08. Estimated completion is 2004-05.

What conditions does trial NCT00304291 study?

This clinical trial studies the following conditions: Neuromyelitis Optica, Myelitis, Transverse, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS.

What interventions are being tested in trial NCT00304291?

The interventions under investigation include: Mitoxantrone (DRUG).

Who is sponsoring clinical trial NCT00304291?

This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00304291 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00304291, the US trial registry maintained by the National Library of Medicine. NCT00304291 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.