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

Phase 4Not Yet RecruitingNCT07699770

Tang-Du Hospital110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD)Neuropathic Pain

Interventions

CrisugabalinDRUG

Crisugabalin 20-40mg bid

Placebo+CrisugabalinDRUG

Placebo+Crisugabalin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

\*\*Inclusion Criteria:\*\* Subjects who meet all of the following criteria will be enrolled in this study: 1. Able to understand and voluntarily sign the written informed consent form; 2. Male or female aged between 18 years (inclusive) and 75 years; 3. Diagnosed with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) according to the International Panel for NMO Diagnosis (IPND, 2015) criteria; 4. Patients with comorbid neuropathic pain, DN4 ≥ 4; no change in medication dosage within the past month; 5. Numeric Rating Scale (NRS) for pain score ≥ 4 at screening; 6. First-time use of Crisugabalin Capsules. \*\*Exclusion Criteria:\*\* Subjects who meet any of the following criteria will not be enrolled in this study: 1. Presence of peripheral neuropathy or pain unrelated to NMOSD that, in the investigator's judgment, may confound the assessment; 2. Known history of allergy to the investigational drug components, or to other drugs with similar chemical structures, or to any excipients; 3. 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; 4. 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.

Locations (10)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

the First Hospital of Tsinghua University

Beijing, Chaoyang, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Jun Guo, MD

CONTACT

86-29-8477 8844 guojun_81@163.com

Data from ClinicalTrials.gov

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