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Efficacy and safety of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica: Multicenter double-blind controlled study using dynamic allocation

Efficacy and safety of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica: Multicenter double-blind controlled study using dynamic allocation - Controlled study of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009195
Enrollment
70
Registered
2012-12-01
Start date
2012-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis optica

Interventions

Plasma exchange (PE group): Will be performed 4 times within 14 days after the efficacy of the steroid pulse therapy has been evaluated, for each session, the final volume of treated plasma is 30mL/kg

Sponsors

Saitama Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with optic neuritis or myelitis who either initially presented with NMO or NMO spectrum disorders suspected to be positive for the anti-AQP4 antibody titer or tested positive for the anti-AQP4 antibody titer, and who have been diagnosed with relapsing NMO or NMO spectrum disorders in a period of acute exacerbation

Exclusion criteria

Exclusion criteria: Patients considered to be due to brain lesions, the only local symptoms and disturbance of consciousness.

Design outcomes

Primary

MeasureTime frame
Change in QOSI score on day 7 after the first course of blood purification therapy

Secondary

MeasureTime frame
Anti-AQP4 antibody titer during evaluation period Initial effect Steroid pulse therapy efficacy rate Crossover study implementation rate Crossover study efficacy Adverse events

Countries

Japan

Contacts

Public ContactKyoichi Nomura

Saitama Medical Center Department of Neurology

049-228-3603

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026