A Phase 4 interventional study of Crisugabalin and Placebo+Crisugabalin in Neuromyelitis Optica Spectrum Disorders (NMOSD) and Neuropathic Pain, sponsored by Tang-Du Hospital. Not yet recruiting at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Tang-Du Hospital · Phase 4, Interventional, and Treatment
Among 72 studies in Neuromyelitis Optica with a site in China — 37 open to participants now, 43 under way, 7 of them phase 3. Neuromyelitis Optica · China.
Among the 72 studies in Neuromyelitis Optica with a site in China, this one is the 9th largest by planned enrollment of the 51 interventional ones that give a count, is one of 12 that started in 2026, is one of 6 in phase 4, reaches primary completion later than 27 of the 42 other live ones, and was the 68th registered.
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
Browse Neuromyelitis Optica studies →37 of the 72 studies in Neuromyelitis Optica with a site in China are open now. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in China
Junwei Hao, MD · Sites in China
Hoffmann-La Roche · Sites in China, United States, Argentina and 6 more countries
Tongji Hospital · Sites in China
Chinese PLA General Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 17 · Phase 3 9 · Phase 4 6
First in 2009; this study’s year is marked. 12 started in 2026.
This study's planned enrollment of 110 is above the median of 29 across 108 interventional studies indexed under Neuromyelitis Optica.
Median enrollment 23 across the 51 interventional studies, 300 across the 21 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 72 have an industry lead sponsor. The 10 most frequent:
Tang-Du Hospital is the lead sponsor of 167 studies on the registry; 78 are open to participants now.
Tang-Du Hospital has 4 studies filed under Neuromyelitis Optica — fewer than ten, so there is no comparison to draw.
19 of the studies in Neuromyelitis Optica with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06724809Phase 3Alexion Pharmaceuticals, Inc.Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD | 2026-12-07 |
| NCT07420296Phase 3Tianjin Medical University General HospitalModified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | 2026-12-31 |
| NCT05199688Phase 3Hoffmann-La RocheA Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) | 2027-03-31 |
| NCT06413654Phase 3Shanghai Jiaolian Drug Research and Development Co., LtdA Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD) | 2027-10-31 |
| NCT05145361Shanghai Pharmaceuticals Holding Co., LtdClinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | 2026-12-15 |
Among the 72 studies in Neuromyelitis Optica with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
**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: (ALT) or aspartate aminotransferase (AST) > 3 × (ULN); 2) Estimated (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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Si meining
Drug: Crisugabalin
Si meining
Drug: Placebo+Crisugabalin
Crisugabalin 20-40mg bid
Placebo+Crisugabalin
Also known as: Placebo
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. * 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)
Time frame: Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment
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
Time frame: Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.
Short-Form McGill Pain Questionnaire (SF-MPQ) score
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
Time frame: 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
* 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.
Time frame: Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment
Penn Spasm Frequency Scale (PSFS) score
* 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.
Time frame: Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment
Hamilton Anxiety Rating Scale (HAMA) score
* 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.
Time frame: Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment
Hamilton Depression Rating Scale (HAMD) score
* 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.
Time frame: 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.
Time frame: Change from baseline during 2 and 10 weeks of treatment
Patient Global Impression of Change (PGIC) score
* 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.
Time frame: 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
* 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.
Time frame: Change from baseline in the EuroQol 5-Dimension 5-Level（EQ-5D-5L） score after 10 weeks of treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Oct 2027, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Crisugabalin