Neuromyelitis Optica Spectrum Disorders (NMOSD)Phase 4TERMINATORNCT07699770
Crisugabalin in NMOSD Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial
A Phase 4 study testing Crisugabalin in people with Neuromyelitis Optica Spectrum Disorders (NMOSD) and Neuropathic Pain, run by Tang-Du Hospital at 10 sites in China.
Trial summary
This study is a multicenter, prospective, randomized, double-blind, placebo-controlled exploratory investigation conducted in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders (NMOSD), Neuropathic Pain
- What is being tested?
- Crisugabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 10 sitesChina
- Study dates
- 15 Jun 2026to 31 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Decai Tian, +8615202282795, decaitian@163.com
the First Hospital of Tsinghua University
Beijing, Chaoyang
Yujuan Jiao, 86+13701352593, spqjiao@126.com
The First Hospital of Jilin University
Changchun, Jinlin
Tao Jin, +8613351505206, jin-tao@jlu.edu.com
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Jinzhou Feng, +8615123202155, fengjinzhou@hotmail.com
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Di Zhong, 86+13766851510, dityan@163.com
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia
Jin Zhen, +8618047192837, 729986341@qq.com
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Linming Zhang, +8618288661591, zlmeek@163.com
The First Hospital of China Medical University
Shenyang, Liaoning
Zhe Wu, +8613889815549, zhe-wu@sina.com
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang Uygur Autonomous Region
Maimaiti Mayinur, +8613565918992, maiynur2@163.com
Tangdu Hospotal
Xi'an, Shaanxi
Jun Guo, 86-29-8477 8844
About this study
Official title: 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.
Read the detailed description
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
- Being tested
- Crisugabalin, Placebo+Crisugabalin
- Keywords
- neuromyelitis optica spectrum disorders, Neuropathic pain, Crisugabalin, NMOSD
- Medical subject headings
- Neuromyelitis Optica, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrisugabalinDrug
Crisugabalin 20-40mg bid
Placebo+CrisugabalinDrug
Also called Placebo
Placebo+Crisugabalin
| Study group | Role | What they receive |
|---|---|---|
| Crisugabalin group | Experimental | Si meining Receives: Drug: Crisugabalin |
| Placebo group | Placebo comparator | Si meining Receives: Drug: Placebo+Crisugabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment
Secondary outcomes (9)
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
Measured: 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:
- 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).
- 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.
- 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline in the EuroQol 5-Dimension 5-Level（EQ-5D-5L） score after 10 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorders (NMOSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699770
- Sponsor's protocol ID
- 202603-06
- Acronym
- TERMINATOR
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No