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

9. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Beijing Tiantan Hospital, Capital Medical University
        • Ta kontakt med:
    • Chaoyang
      • Beijing, Chaoyang, Kina
        • the First Hospital of Tsinghua University
        • Ta kontakt med:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina
        • The First Affiliated Hospital of Chongqing Medical University
        • Ta kontakt med:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • The First Affiliated Hospital of Harbin Medical University
        • Ta kontakt med:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Kina
        • Inner Mongolia People's Hospital
        • Ta kontakt med:
    • Jinlin
      • Changchun, Jinlin, Kina
        • The First Hospital of Jilin University
        • Ta kontakt med:
    • Liaoning
      • Shenyang, Liaoning, Kina
        • The First Hospital of China Medical University
        • Ta kontakt med:
    • Shaanxi
      • Xi'an, Shaanxi, Kina
        • Tangdu Hospotal
        • Ta kontakt med:
          • Jun Guo
          • Telefonnummer: 86-29-8477 8844
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, Kina
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Ta kontakt med:
    • Yunnan
      • Kunming, Yunnan, Kina
        • The First Affiliated Hospital of Kunming Medical University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

**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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Crisugabalin group
Si meining
Legemiddel: Crisugabalin
Crisugabalin 20-40mg bid
Placebo komparator: Placebo group
Si meining
Legemiddel: Placebo+Crisugabalin
Placebo+Crisugabalin
Andre navn:
  • Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numeric Rating Scale (NRS) Pain Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numeric Rating Scale (NRS) response rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tang-Du Hospital

Etterforskere

  • Hovedetterforsker: Jun Guo, Tang-Du Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

15. april 2026

Først innsendt som oppfylte QC-kriteriene

9. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202603-06

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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