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 groupsLocations
10Beijing Tiantan Hospital, Capital Medical University BeijingBeijing Municipality, China
the First Hospital of Tsinghua University BeijingChaoyang, China
The First Affiliated Hospital of Chongqing Medical University ChongqingChongqing Municipality, China
The First Affiliated Hospital of Harbin Medical University HarbinHeilongjiang, China
Sponsors and collaborators
Tang-Du Hospital
Lead sponsor
Source ClinicalTrials.gov