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Crisugabalin in NMOSD Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial (TERMINATOR)

9 de julho de 2026 atualizado por: Tang-Du Hospital

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

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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

To evaluate the efficacy and safety of Crisugabalin, a China-developed novel third-generation calcium channel modulator, for neuropathic pain in neuromyelitis optica spectrum disorder (NMOSD). Patients are randomized 1:1 to receive Crisugabalin or placebo for 2 weeks , followed by an 8-week open-label extension period .The main questions of this study aim to answer are:

Does Crisugabalin lower pain scores after 2 weeks and 10 weeks? What medical problems do participants have when taking crisugabalin? This trial is to compare Crisugabalin to a placebo for the first 2 weeks to see if it reduces pain.

Participants will:

Take Crisugabalin or a placebo twice daily for 2 weeks (double-blind) Then take Crisugabalin for 8 more weeks (open-label) Visit the clinic at weeks 1, 2, 4, and 8 Complete questionnaires about pain, sleep, spasms, anxiety, and depression Last updated on December 2, 2025

Tipo de estudo

Intervencional

Inscrição (Estimado)

110

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Tiantan Hospital, Capital Medical University
        • Contato:
    • Chaoyang
      • Beijing, Chaoyang, China
        • the First Hospital of Tsinghua University
        • Contato:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
        • Contato:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The First Affiliated Hospital of Harbin Medical University
        • Contato:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Inner Mongolia People's Hospital
        • Contato:
    • Jinlin
      • Changchun, Jinlin, China
        • The First Hospital of Jilin University
        • Contato:
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
        • Contato:
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Tangdu Hospotal
        • Contato:
          • Jun Guo
          • Número de telefone: 86-29-8477 8844
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Contato:
    • Yunnan
      • Kunming, Yunnan, China
        • The First Affiliated Hospital of Kunming Medical University
        • Contato:
          • Linming Zhang
          • Número de telefone: +8618288661591
          • E-mail: zlmeek@163.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

**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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Crisugabalin group
Si meining
Medicamento: Crisugabalin
Crisugabalin 20-40mg bid
Comparador de Placebo: Placebo group
Si meining
Medicamento: Placebo+Crisugabalin
Placebo+Crisugabalin
Outros nomes:
  • Placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Numeric Rating Scale (NRS) Pain Score
Prazo: Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment

Patients rate their average pain intensity over the past 24 hours on an 11-point scale (0-10), with 0 = no pain and 10 = worst possible pain.

  • Min / Max: 0 / 10
  • Severity relationship:** Higher scores indicate greater pain severity. Pain levels are categorized as: Mild (1-3), Moderate (4-6), Severe (7-10)
Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Numeric Rating Scale (NRS) response rate
Prazo: Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.
Proportion of subjects with ≥30% and ≥50% reduction in NRS from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period
Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.
Short-Form McGill Pain Questionnaire (SF-MPQ) score
Prazo: Change from baseline in the Short-Form McGill Pain Questionnaire (SF-MPQ) score after 2 and 10 weeks of treatment

The Short-Form McGill Pain Questionnaire (SF-MPQ) comprises three main components for pain assessment:

  1. Pain Rating Index (PRI): This includes 11 sensory descriptors and 4 affective descriptors. Each item is rated on a 4-point intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The PRI yields a total score ranging from 0 to 45 (sensory subscale: 0-33; affective subscale: 0-12).
  2. Visual Analogue Scale (VAS): A 10-cm unmarked horizontal line anchored by 0 = no pain and 10 = worst possible pain. Patients mark a cross on the line to indicate their average pain level over the past 24 hours. The score is determined by measuring the distance from the 0 end to the mark (in cm), or by reading directly from a scale on the reverse side.
  3. Present Pain Intensity (PPI): A 6-point scale ranging from 0 = no pain to 5 = excruciating pain. Patients select the level that best matches their subjective pain experience at the present moment.

Score Ranges:

PRI: 0 - 45 VAS: 0 - 10 PPI: 0 - 5
Change from baseline in the Short-Form McGill Pain Questionnaire (SF-MPQ) score after 2 and 10 weeks of treatment
Daily Sleep Interference Scale (DSIS) score
Prazo: Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment
  • Interpretation:Patients rate how much pain interfered with sleep over the past 24 hours on a 0-10 scale, where 0 = pain does not interfere with sleep and 10 = completely unable to sleep.
  • Min / Max:0 / 10
  • Severity relationship:** Higher scores indicate greater sleep disruption due to pain.
Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment
Penn Spasm Frequency Scale (PSFS) score
Prazo: Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment
  • Interpretation: Two parts - spasm frequency (0-4, where higher = more frequent) and, if present, severity (1 = mild, 2 = moderate, 3 = severe). If frequency = 0, severity is not assessed.
  • Min / Max:Frequency: 0-4; Severity (if spasms present): 1-3
  • Severity relationship: Higher frequency and severity scores indicate more problematic muscle spasms.
Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment
Hamilton Anxiety Rating Scale (HAMA) score
Prazo: Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment
  • Interpretation:A clinician-rated scale with 14 items, each scored 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Total score reflects anxiety severity.
  • Min / Max: 0 / 56
  • Severity relationship: Higher total scores indicate more severe anxiety.
Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment
Hamilton Depression Rating Scale (HAMD) score
Prazo: Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment
  • Interpretation: Clinician-rated scale for depressive symptoms. Most items scored 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. A few items use a 0-2 scale (0 = absent, 1 = mild-moderate, 2 = severe).
  • Min / Max:0 / 74 (approximate for 24 items)
  • Severity relationship: Higher total scores indicate more severe depression.
Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment
Incidence of adverse reactions
Prazo: Change from baseline during 2 and 10 weeks of treatment
Treatment-emergent adverse events (TEAEs) and the incidence of TEAEs during the study period for Crisugabalin and placebo.
Change from baseline during 2 and 10 weeks of treatment
Patient Global Impression of Change (PGIC) score
Prazo: Change from baseline in the Patient Global Impression of Change (PGIC) score after 10 weeks of treatment
  • Interpretation: A 7-point scale assessing overall improvement since treatment began.
  • 1 = Very much improved
  • 2 = Much improved
  • 3 = Minimally improved
  • 4 = No change
  • 5 = Minimally worse
  • 6 = Much worse
  • 7 = Very much worse
  • Min / Max: 1 / 7
  • Severity relationship: Lower scores indicate greater improvement; higher scores indicate worsening.
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
Prazo: Change from baseline in the EuroQol 5-Dimension 5-Level（EQ-5D-5L） score after 10 weeks of treatment
  • Interpretation: Measures health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated 1 = no problems to 5 = extreme problems. A VAS from 0 (worst imaginable health) to 100 (best imaginable health) is also included.
  • Min / Max: Dimension scores: 1-5 per dimension; VAS: 0-100
  • Severity relationship:Higher dimension scores indicate worse function/more problems; higher VAS score indicates better overall health.
Change from baseline in the EuroQol 5-Dimension 5-Level（EQ-5D-5L） score after 10 weeks of treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tang-Du Hospital

Investigadores

  • Investigador principal: Jun Guo, Tang-Du Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

31 de outubro de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2026

Primeira postagem (Real)

13 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 202603-06

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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