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Recruiting NCT07196657

The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia

No phase Interventional Fibromyalgia Pregabalin Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pregabalin, Crisugabalin.
Who it may be relevant to
Registry conditions: Fibromyalgia, Pregabalin, Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Crisugabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Overview

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. crisugabalin, a new highly selective α2δ ligand, has shown potential in animal models or preliminary clinical trials, but there is insufficient evidence for its application in FM. This study aims to explore the effectiveness and safety of pregabalin or crisugabalin in treating FM, with the aim of providing a better treatment option for FM patients.

Interventions

  • Drug Pregabalin
    For the pregabalin group, treatment will be initiated at a dosage of 150 mg daily, administered into 2 or 3 divided doses. After 3 to 7 days, the dose will be titrated to 300 mg per day, with subsequent incremental increases of 150 mg daily permitted at 3-day to 7-day intervals based on therapeutic response and tolerability, up to a maximum dose of 450 mg daily.
  • Drug Crisugabalin
    For the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily.

Primary outcome measures

  • The proportion of patients achieving pain relief [Time frame: At the 12-weeks]
Secondary outcome measures (11)
  • The average pain intensity [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The worst pain intensity [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • Dose of crisugabalin or pregabalin [Time frame: At the week 1, 2, 4, 8, 12]
  • Average weekly consumption of rescue analgesics [Time frame: at weeks 4, 8, 12]
  • The Revised FM Impact Questionnaire [Time frame: At the weeks 4, 8, and 12]
  • The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subsc [Time frame: At the weeks 4, 8, and 12]
  • The short-form 36 Health Survey (SF-36) [Time frame: At the weeks 4, 8, and 12]
  • Patient Global Impression of Change Scale [Time frame: at week 12]
  • The Medical Outcomes Study Sleep Scale (MOS) [Time frame: At the weeks 4, 8, and 12]
  • The Beck Depression Inventory-Ⅱ (BD-Ⅱ) [Time frame: At the weeks 4, 8, and 12]
  • Adverse Events [Time frame: Through study completion, an average of 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Publications

  • Liu M, Li R, Zhou H, Xie Z, He Y, Ren F, Feng X, Fan B, Li S, Luo F, Zhang D. The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients: Protocol for a Prospective Randomized Open Blinded-Endpoint (PROBE) Study. J Pain Res. 2026 Mar 3;19:580694. doi: 10.2147/JPR.S580694. eCollection 2026. PMID 41800444

Identifiers

NCT: NCT07196657 · KY2025-217-03-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗