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

ConditionsNeuromyelitis Optica Spectrum Disorders (NMOSD)Neuropathic Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Crisugabalin

    Drug

    Crisugabalin 20-40mg bid

  • Placebo+Crisugabalin

    Drug

    Placebo+Crisugabalin

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Crisugabalin groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment

Secondary outcomes

1

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.
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

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