Could a new drug ease nerve pain in a rare disease?

NCT ID NCT07699770

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, China

  • Tangdu Hospotal

    Xi'an, Shaanxi, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Hospital of Jilin University

    Changchun, Jinlin, China

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang Uygur Autonomous Region, China

  • the First Hospital of Tsinghua University

    Beijing, Chaoyang, China

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