Crisugabalin in NMOSD Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial
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
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
Treatments tested in this trial
- Crisugabalin
- Placebo+Crisugabalin
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov