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Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder

ConditionNeuromyelitis Optica Spectrum Disorder Attack
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyushu University

About this trial

The primary objective of this study is to evaluate the safety and tolerability of sivelestat sodium hydrate administered in combination with standard steroid pulse therapy in patients experiencing an acute NMOSD attack. Safety assessments will include adverse events, laboratory parameters, vital signs, and other clinically relevant findings. In addition, the study will explore whether the addition of sivelestat sodium hydrate to standard steroid pulse therapy improves neurological outcomes in patients with acute NMOSD.

Participants will receive intravenous sivelestat sodium hydrate at a dose of 4.8 mg/kg/day administered as a continuous infusion (0.2 mg/kg/hour) for 5 consecutive days, receive steroid pulse therapy according to the study protocol, and be followed for 28 days after treatment initiation for safety and efficacy evaluations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with anti-AQP4 antibody-positive NMOSD according to the international diagnostic criteria for NMOSD (Wingerchuk, Neurology 2015).

Patients whose FS domain has worsened by at least 1 point due to relapse.

Patients with one or more relapse lesions identified on MRI (however, if the relapse is considered to have occurred in the same location as an existing MRI lesion neurologically, identification of a new relapse lesion is not required).

Patients aged 18 years or older at the time of obtaining consent.

Disqualifiers

Patients with multi-organ dysfunction involving 4 or more organs.

Patients with severe chronic respiratory disease.

Patients with autoimmune diseases other than NMOSD that are expected to require additional treatment during the study period.

Patients with active systemic bacterial, viral, or fungal infections.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sivelestat sodium hydrate

    Drug

    Sivelestat sodium hydrate is administered intravenously at a dose of 4.8 mg/kg/day as a continuous infusion (0.2 mg/kg/hour) for 5 consecutive days in combination with steroid pulse therapy in patients with acute NMOSD attacks.

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: SivelestatExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Time frame
4 weeks

Secondary outcomes

1

Change from baseline in body temperature at 3 hours, Day 2, Day 3, Day 4, Day 5, and Day 6 after the start of investigational product administration.

Time frame
6 days
2

Change from baseline in blood pressure at 3 hours, Day 2, Day 3, Day 4, Day 5, and Day 6 after the start of investigational product administration.

Time frame
6 days
3

Change from baseline in pulse rate at 3 hours, Day 2, Day 3, Day 4, Day 5, and Day 6 after the start of investigational product administration.

Time frame
6 days
4

Change from baseline in percutaneous arterial oxygen saturation at 3 hours, Day 2, Day 3, Day 4, Day 5, and Day 6 after the start of investigational product administration.

Time frame
6 days

Other outcomes

Sponsors and contacts

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Kyushu University

Lead sponsor

Source ClinicalTrials.gov
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