Crisugabalin in NMOSD Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial (TERMINATOR)
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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Jun Guo, MD
- Telefonnummer: 86-29-8477 8844
- E-Mail: guojun_81@163.com
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China
- Beijing Tiantan Hospital, Capital Medical University
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Kontakt:
- Decai Tian
- Telefonnummer: +8615202282795
- E-Mail: decaitian@163.com
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Chaoyang
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Beijing, Chaoyang, China
- the First Hospital of Tsinghua University
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Kontakt:
- Yujuan Jiao
- Telefonnummer: 86+13701352593
- E-Mail: spqjiao@126.com
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China
- The First Affiliated Hospital of Chongqing Medical University
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Kontakt:
- Jinzhou Feng
- Telefonnummer: +8615123202155
- E-Mail: fengjinzhou@hotmail.com
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Heilongjiang
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Harbin, Heilongjiang, China
- The First Affiliated Hospital of Harbin Medical University
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Kontakt:
- Di Zhong
- Telefonnummer: 86+13766851510
- E-Mail: dityan@163.com
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Inner Mongolia
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Hohhot, Inner Mongolia, China
- Inner Mongolia People's Hospital
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Kontakt:
- Jin Zhen
- Telefonnummer: +8618047192837
- E-Mail: 729986341@qq.com
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Jinlin
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Changchun, Jinlin, China
- The First Hospital of Jilin University
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Kontakt:
- Tao Jin
- Telefonnummer: +8613351505206
- E-Mail: jin-tao@jlu.edu.com
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Liaoning
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Shenyang, Liaoning, China
- The First Hospital of China Medical University
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Kontakt:
- Zhe Wu
- Telefonnummer: +8613889815549
- E-Mail: zhe-wu@sina.com
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Shaanxi
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Xi'an, Shaanxi, China
- Tangdu Hospotal
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Kontakt:
- Jun Guo
- Telefonnummer: 86-29-8477 8844
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Xinjiang Uygur Autonomous Region
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Ürümqi, Xinjiang Uygur Autonomous Region, China
- Xinjiang Uygur Autonomous Region People's Hospital
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Kontakt:
- Maimaiti Mayinur
- Telefonnummer: +8613565918992
- E-Mail: maiynur2@163.com
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Yunnan
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Kunming, Yunnan, China
- The First Affiliated Hospital of Kunming Medical University
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Kontakt:
- Linming Zhang
- Telefonnummer: +8618288661591
- E-Mail: zlmeek@163.com
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
**Inclusion Criteria:**
Subjects who meet all of the following criteria will be enrolled in this study:
- Able to understand and voluntarily sign the written informed consent form;
- Male or female aged between 18 years (inclusive) and 75 years;
- Diagnosed with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) according to the International Panel for NMO Diagnosis (IPND, 2015) criteria;
- Patients with comorbid neuropathic pain, DN4 ≥ 4; no change in medication dosage within the past month;
- Numeric Rating Scale (NRS) for pain score ≥ 4 at screening;
- First-time use of Crisugabalin Capsules.
**Exclusion Criteria:**
Subjects who meet any of the following criteria will not be enrolled in this study:
- Presence of peripheral neuropathy or pain unrelated to NMOSD that, in the investigator's judgment, may confound the assessment;
- Known history of allergy to the investigational drug components, or to other drugs with similar chemical structures, or to any excipients;
- 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;
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: Crisugabalin group
Si meining
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Crisugabalin 20-40mg bid
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Placebo-Komparator: Placebo group
Si meining
|
Placebo+Crisugabalin
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Numeric Rating Scale (NRS) Pain Score
Zeitfenster: Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment
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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.
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Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Numeric Rating Scale (NRS) response rate
Zeitfenster: Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.
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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
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Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.
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Short-Form McGill Pain Questionnaire (SF-MPQ) score
Zeitfenster: Change from baseline in the Short-Form McGill Pain Questionnaire (SF-MPQ) score after 2 and 10 weeks of treatment
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The Short-Form McGill Pain Questionnaire (SF-MPQ) comprises three main components for pain assessment:
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
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Daily Sleep Interference Scale (DSIS) score
Zeitfenster: Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment
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Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment
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Penn Spasm Frequency Scale (PSFS) score
Zeitfenster: Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment
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Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment
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Hamilton Anxiety Rating Scale (HAMA) score
Zeitfenster: Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment
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Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment
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Hamilton Depression Rating Scale (HAMD) score
Zeitfenster: Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment
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Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment
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Incidence of adverse reactions
Zeitfenster: Change from baseline during 2 and 10 weeks of treatment
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Treatment-emergent adverse events (TEAEs) and the incidence of TEAEs during the study period for Crisugabalin and placebo.
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Change from baseline during 2 and 10 weeks of treatment
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Patient Global Impression of Change (PGIC) score
Zeitfenster: Change from baseline in the Patient Global Impression of Change (PGIC) score after 10 weeks of treatment
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Change from baseline in the Patient Global Impression of Change (PGIC) score after 10 weeks of treatment
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EuroQol 5-Dimension 5-Level(EQ-5D-5L) score
Zeitfenster: Change from baseline in the EuroQol 5-Dimension 5-Level(EQ-5D-5L) score after 10 weeks of treatment
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Change from baseline in the EuroQol 5-Dimension 5-Level(EQ-5D-5L) score after 10 weeks of treatment
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Jun Guo, Tang-Du Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Neuromuskuläre Erkrankungen
- Autoimmunerkrankungen
- Erkrankungen des Immunsystems
- Erkrankungen des peripheren Nervensystems
- Augenkrankheiten
- Demyelinisierende Autoimmunerkrankungen, ZNS
- Autoimmunerkrankungen des Nervensystems
- Demyelinisierende Krankheiten
- Myelitis, quer
- Optikusneuritis
- Sehnervenerkrankungen
- Erkrankungen der Hirnnerven
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Neuralgie
- Neuromyelitis optica
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 202603-06
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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