FibromyalgiaNCT07196657
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
A study testing Pregabalin and Crisugabalin in people with Fibromyalgia and Pregabalin, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Pregabalin, Pain
- What is being tested?
- Pregabalin and Crisugabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,116 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing
Fang Luo, +8613611326978, 13611326978@163.com
About this study
Official title: Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Crisugabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
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.
- Conditions
- Fibromyalgia, Pregabalin, Pain
- Being tested
- Pregabalin, Crisugabalin
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
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.
CrisugabalinDrug
For the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Active comparator | Not described Receives: Drug: Pregabalin |
| Crisugabalin group | Experimental | Not described Receives: Drug: Crisugabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving pain relief
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.
Measured: At the 12-weeks
Secondary outcomes (11)
The average pain intensity
The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Measured: At the weeks 1, 2, 4, 8, and 12
The worst pain intensity
The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Measured: At the weeks 1, 2, 4, 8, and 12
Dose of crisugabalin or pregabalin
the dose of experimental drug
Measured: At the week 1, 2, 4, 8, 12
Average weekly consumption of rescue analgesics
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.
Measured: at weeks 4, 8, 12
The Revised FM Impact Questionnaire
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.
Measured: At the weeks 4, 8, and 12
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subsc
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.
Measured: At the weeks 4, 8, and 12
The short-form 36 Health Survey (SF-36)
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.
Measured: At the weeks 4, 8, and 12
Patient Global Impression of Change Scale
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.
Measured: at week 12
The Medical Outcomes Study Sleep Scale (MOS)
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.
Measured: At the weeks 4, 8, and 12
The Beck Depression Inventory-Ⅱ (BD-Ⅱ)
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.
Measured: At the weeks 4, 8, and 12
Adverse Events
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.
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The First Affiliated Hospital of Nanchang University, Peking University Third Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Zhongnan Hospital, Xiangya Hospital of Central South University, The Affiliated Hospital of Yanbian University, The Second Hospital University of South China, LanZhou University
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196657
- Sponsor's protocol ID
- KY2025-217-03-02
- Status last verified
- Nov 2025
- First submitted
- 20 Sep 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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.
PubMed 41800444
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Crisugabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07196657
- Acronym / sponsor ID
- KY2025-217-03-02
- Conditions
- Fibromyalgia, Pregabalin, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,116 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The First Affiliated Hospital of Nanchang University, Peking University Third Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Zhongnan Hospital, Xiangya Hospital of Central South University, The Affiliated Hospital of Yanbian University, The Second Hospital University of South China, LanZhou University
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Active comparator | Drug: Pregabalin |
| Crisugabalin group | Experimental | Drug: Crisugabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinFor 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 | Pregabalin group |
| CrisugabalinFor the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily. | Drug | Crisugabalin group |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 41800444Liu 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.
- Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315Link provided by the sponsor.
- Domon Y, Arakawa N, Inoue T, Matsuda F, Takahashi M, Yamamura N, et al. Binding Characteristics and Analgesic Effects of Mirogabalin, a Novel Ligand for the α2δ Subunit of Voltage-Gated Calcium Channels. J Pharmacol Exp Ther. 2018;365(3):573-82. doi: 10.Link provided by the sponsor.
- Gou X, Yu X, Bai D, Tan B, Cao P, Qian M, et al. Pharmacology and Mechanism of Action of HSK16149, a Selective Ligand of α2δ Subunit of Voltage-Gated Calcium Channel with Analgesic Activity in Animal Models of Chronic Pain. J Pharmacol Exp Ther. 2021;376Link provided by the sponsor.
- Chen Q, Wu Q, Song R, Wang Y, Zhang M, Li F, et al. A phase I study to evaluate the safety, tolerability, and pharmacokinetics of a novel, potent GABA analog HSK16149 in healthy Chinese subjects. Front Pharmacol. 2023;14:1296672.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Crisugabalin in people with Fibromyalgia and Pregabalin, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo, M.D. (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving pain relief (time frame: At the 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07196657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.