Could a new drug ease nerve pain in a rare disease?
NCT ID NCT07699770
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This trial investigates whether the drug crisugabalin can reduce neuropathic pain in people with neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune condition affecting the nerves. Participants will receive either crisugabalin or a placebo, and their pain levels will be tracked using a standard rating scale. The study aims to see if crisugabalin offers meaningful pain relief for this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- crisugabalin
- What this could lead to
- If it works, this could provide a new option for managing chronic pain in NMOSD, improving quality of life.
- What could go wrong
- This is an early exploratory trial with a small number of participants, so results may not be conclusive or apply to everyone. Side effects of crisugabalin are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\*\*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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
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Tangdu Hospotal
Xi'an, Shaanxi, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
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The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
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The First Hospital of China Medical University
Shenyang, Liaoning, China
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The First Hospital of Jilin University
Changchun, Jinlin, China
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Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang Uygur Autonomous Region, China
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the First Hospital of Tsinghua University
Beijing, Chaoyang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Zapping the brain to loosen stiff legs and quiet nerve pain in MS?
- Ancient Mind-Body practice put to the test for spinal cord injury pain
- Can a targeted drug curb the devastating attacks of NMOSD?
- Can a skin injection of ketamine and lidocaine tame CRPS pain?
- Could painkillers quietly disrupt your hormones?