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

NCT07699770 | Not Yet Recruiting Phase 4

• 1 other identifier: 202603-06
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 10

Brief Summary

This study is a multicenter, prospective, randomized, double-blind, placebo-controlled exploratory investigation conducted in China.

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD); Neuropathic Pain

Keywords

neuromyelitis optica spectrum disorders; Neuropathic pain; Crisugabalin; NMOSD

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.

• Short-Form McGill Pain Questionnaire (SF-MPQ) score

  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

Study Arms (2)

Crisugabalin group

EXPERIMENTAL

Si meining

Drug: Crisugabalin

Placebo group

PLACEBO COMPARATOR

Si meining

Drug: Placebo+Crisugabalin

Interventions

Crisugabalin DRUG

Crisugabalin 20-40mg bid

Crisugabalin group

Placebo+Crisugabalin DRUG

Placebo+Crisugabalin

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• \) 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (10)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

the First Hospital of Tsinghua University

Beijing, Chaoyang, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Location

The First Hospital of Jilin University

Changchun, Jinlin, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Tangdu Hospotal

Xi'an, Shaanxi, China

Location

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, Xinjiang Uygur Autonomous Region, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica; Neuralgia

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Guo

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Guo, MD

CONTACT

86-29-8477 8844; guojun_81@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: July 13, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)