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This study is a multicenter, prospective, randomized, double-blind, placebo-controlled exploratory investigation conducted in China.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisugabalin group | Experimental | Si meining |
|
| Placebo group | Placebo Comparator | Si meining |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisugabalin | Drug | Crisugabalin 20-40mg bid |
| |
| Placebo+Crisugabalin |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score | 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.
| Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) response rate | 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 |
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**Inclusion Criteria:**
Subjects who meet all of the following criteria will be enrolled in this study:
**Exclusion Criteria:**
Subjects who meet any of the following criteria will not be enrolled in this study:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo, MD | Contact | 86-29-8477 8844 | guojun_81@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| Drug |
Placebo+Crisugabalin |
|
|
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 |
| Daily Sleep Interference Scale (DSIS) score |
| Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment |
| Penn Spasm Frequency Scale (PSFS) score |
| Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment |
| Hamilton Anxiety Rating Scale (HAMA) score |
| Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment |
| Hamilton Depression Rating Scale (HAMD) score |
| Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment |
| Incidence of adverse reactions | 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 |
| 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 |
| the First Hospital of Tsinghua University | Beijing | Chaoyang | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
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| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
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| Inner Mongolia People's Hospital | Hohhot | Inner Mongolia | China |
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| The First Hospital of Jilin University | Changchun | Jinlin | China |
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| The First Hospital of China Medical University | Shenyang | Liaoning | China |
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| Tangdu Hospotal | Xi'an | Shaanxi | China |
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| Xinjiang Uygur Autonomous Region People's Hospital | Ürümqi | Xinjiang Uygur Autonomous Region | China |
|
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
|
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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