Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07196657

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Pregabalin Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

+8613611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

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.

Crisugabalin

Drug

For the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily.

Primary outcomes

  1. The proportion of patients achieving pain relief

    Time frame: At the 12-weeks

    The proportion of patients achieving pain relief defined as the proportion of patients whose baseline average pain intensity is reduced by at least 50%. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

Secondary outcomes

  1. The average pain intensity

    Time frame: At the weeks 1, 2, 4, 8, and 12

    The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  2. The worst pain intensity

    Time frame: At the weeks 1, 2, 4, 8, and 12

    The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  3. Dose of crisugabalin or pregabalin

    Time frame: At the week 1, 2, 4, 8, 12

    the dose of experimental drug

  4. Average weekly consumption of rescue analgesics

    Time frame: at weeks 4, 8, 12

    Acetaminophen will be permitted as rescue medication for FM-related pain, at doses up to 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use, including dose and frequency, will be recorded prospectively.

  5. The Revised FM Impact Questionnaire

    Time frame: At the weeks 4, 8, and 12

    The Revised FM Impact Questionnaire is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. The total score ranges from 0 to 100, with higher values indicating worse health status.

  6. The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subsc

    Time frame: At the weeks 4, 8, and 12

    The BPI-S assesses pain intensity over the past 24 hours, including 4 items. The BPI-I evaluates the degree to which pain interferes with daily activities, comprising 7 items. Each BPI item is rated on a 0 to 10 NRS, with 0 represents no pain or does not interfere, and 10 represents worst pain imaginable or interferes completely. Higher scores indicate greater pain severity or interfere.

  7. The short-form 36 Health Survey (SF-36)

    Time frame: At the weeks 4, 8, and 12

    The SF-36 assesses health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.

  8. Patient Global Impression of Change Scale

    Time frame: at week 12

    A 7-point patient-reported Likert scale for evaluating subjective overall change in health/symptoms from baseline, used to assess treatment efficacy in clinical research and practice.

  9. The Medical Outcomes Study Sleep Scale (MOS)

    Time frame: At the weeks 4, 8, and 12

    The MOS uses a 6-point scale to evaluate various dimensions of sleep, consisting of 12 items. A score of 1 indicates persistent presence, with a score of 6 denotes complete absence.

  10. The Beck Depression Inventory-Ⅱ (BD-Ⅱ)

    Time frame: At the weeks 4, 8, and 12

    The BD-Ⅱ employs a 4-point scale (ranging from 0 to 3) to evaluate the severity of depressive symptoms, comprising 21 items in total. A score of 0 indicates the absence of symptoms, while a score of 3 reflects severe symptomatology.

  11. Adverse Events

    Time frame: Through study completion, an average of 12 weeks

    Adverse Events are defined as events that occur the course of treatment, were not present before prior to the intervention, or represent a worsening of pre-existing conditions. These events will be systematically documented and categorized by severity into grades such as mild, moderate, severe, or life-threatening.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo, M.D.

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • China-Japan Friendship Hospital
  • LanZhou University
  • Peking University Third Hospital
  • The Affiliated Hospital of Yanbian University
  • The First Affiliated Hospital of Nanchang University
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The Second Hospital University of South China
  • Xiangya Hospital of Central South University
  • Zhongnan Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.