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New drug crisugabalin takes on pregabalin in fibromyalgia pain showdown

NCT ID NCT07196657

Symptom relief Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two medications, pregabalin and a newer drug called crisugabalin, to see which works better for easing fibromyalgia pain. Over 1,100 adults with moderate to severe fibromyalgia will take one of the two drugs, and researchers will measure how many get at least 50% pain relief. The goal is to find a more effective treatment option for this chronic pain condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pregabalin and crisugabalin
What this could lead to
If successful, this could point toward a more effective pain relief option for people with fibromyalgia.
What could go wrong
This is an early-stage comparison study, not a cure. The new drug may not work better than the existing one, and side effects are possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,116 people

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

Started

Sep 2025

Expected to finish

Aug 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 years and older

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: * Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria; * Aged over 18 years old; * Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM; * Baseline numeric rating scale (NRS) score of 4 or higher; * Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range; * Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m²; * Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements; Exclusion Criteria: * Previous allergic reactions to pregabalin, crisugabalin, or any of their excipients; * Prior diagnosis of epilepsy or depression requiring antidepressant therapy; * Women who are pregnant or breastfeeding; * Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment; * Suffering from acute or chronic pain disorders other than FM.

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Conditions

The condition(s) this trial relates to.

fibromyalgia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia Pain Pregabalin

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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, Beijing, Beijing 100070

    RECRUITING

    Beijing, China

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