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Efficacy and Safety of Crisugabalin in Treating Neuropathic Pain Related to Neuromyelitis Optica Spectrum Disorders: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled, Exploratory Trial
Not yet recruitingPhase 4NMOSDNCT07699770

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Crisugabalin

Placebo or sham

  • Placebo+Crisugabalin

What it measured

Main measures

  • Numeric Rating Scale (NRS) Pain Score

    Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment

    Pain

Other measures (9)

  • Numeric Rating Scale (NRS) response rate

    Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.

  • Short-Form McGill Pain Questionnaire (SF-MPQ) score

    Change from baseline in the Short-Form McGill Pain Questionnaire (SF-MPQ) score after 2 and 10 weeks of treatment

    Pain

  • Daily Sleep Interference Scale (DSIS) score

    Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment

    PainMood and sleep

  • Penn Spasm Frequency Scale (PSFS) score

    Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment

    Spasticity

  • Hamilton Anxiety Rating Scale (HAMA) score

    Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment

    Mood and sleep

  • Hamilton Depression Rating Scale (HAMD) score

    Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment

    Mood and sleep

  • Incidence of adverse reactions

    Change from baseline during 2 and 10 weeks of treatment

    Safety

  • Patient Global Impression of Change (PGIC) score

    Change from baseline in the Patient Global Impression of Change (PGIC) score after 10 weeks of treatment

  • EuroQol 5-Dimension 5-Level（EQ-5D-5L） score

    Change from baseline in the EuroQol 5-Dimension 5-Level（EQ-5D-5L） score after 10 weeks of treatment

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

Who could take part

NMOSD · 18 to 75

**Inclusion Criteria:** Subjects who meet all of the following criteria will be enrolled in this study: 1. Able to understand and voluntarily sign the written informed consent form; 2. Male or female aged between 18 years (inclusive) and 75 years; 3. Diagnosed with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) according to the International Panel for NMO Diagnosis (IPND, 2015) criteria; 4. Patients with comorbid neuropathic pain, DN4 ≥ 4; no change in medication dosage within the past month; 5. Numeric Rating Scale (NRS) for pain score ≥ 4 at screening; 6. First-time use of Crisugabalin Capsules. **Exclusion Criteria:** Subjects who meet any of the following criteria will not be enrolled in this study: 1. Presence of peripheral neuropathy or pain unrelated to NMOSD that, in the investigator's judgment, may confound the assessment; 2. Known history of allergy to the investigational drug components, or to other drugs with similar chemical structures, or to any excipients; 3. Prior use of pregabalin ≥ 300 mg/day, gabapentin ≥ 1200 mg/day, or mirogabalin ≥ 30 mg/day with lack of clinical efficacy as judged by the investigator; 4. Severe liver or kidney function abnormalities, meeting any of the following clinical laboratory findings: 1) Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); 2) Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m² (calculated using the simplified MDRD formula); 5. Women who are pregnant, planning to become pregnant during the study period, or currently breastfeeding; subjects who are unwilling to use reliable contraceptive measures (including condoms, spermicides, intrauterine devices, etc.) from the time of signing the ICF until 28 days after the last dose of the investigational drug; 6. Current use of IL-6 receptor blockers (e.g., tocilizumab, satralizumab); 7. History of suicidal behavior or suicidal ideation; 8. Participation in any other clinical study within 30 days prior to screening; 9. The investigator determines that there are other situations in which participation in the study is inappropriate.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

This study is a multicenter, prospective, randomized, double-blind, placebo-controlled exploratory investigation conducted in China.

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History

    1. Started

      Jun 2026

    2. Main results due

      Oct 2027

    3. Finished

      Dec 2027

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