An interventional study of Mirogabalin and Pregabalin in Fibromyalgia, Pregabalin and Mirogabalin, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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Among 29 studies in Fibromyalgia with a site in China — 14 open to participants now, 14 under way, none of them phase 3. Fibromyalgia · China.
Among the 29 studies in Fibromyalgia with a site in China, this one is the 3rd largest by planned enrollment of the 23 interventional ones that give a count, is one of 10 that started in 2025, is one of 19 with no phase, reaches primary completion later than 3 of the 13 other live ones, and was the 18th registered.
1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →14 of the 29 studies in Fibromyalgia with a site in China are open now. Recruiting first, the newest first:
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 161 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 97 (60%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 10 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 674 is above the median of 60 across 938 interventional studies indexed under Fibromyalgia.
Median enrollment 120 across the 23 interventional studies, 344 across the 6 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 29 have an industry lead sponsor. The 10 most frequent:
Beijing Tiantan Hospital is the lead sponsor of 491 studies on the registry; 295 are open to participants now.
Beijing Tiantan Hospital has 9 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
7 of the studies in Fibromyalgia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07186751Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia | 2027-06-30 |
| NCT07157852Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia | 2027-06-30 |
| NCT07196657Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia | 2027-06-30 |
| NCT07230197Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia | 2027-06-30 |
| NCT07208357Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia | 2027-06-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 29 studies in Fibromyalgia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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. Mirogabalin, 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 mirogabalin in treating FM, with the aim of providing a better treatment option for FM patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pregabalin
Drug: Mirogabalin
For the mirogabalin group, therapy will begin at 5mg twice daily. If the pain will remain inadequately controlled after one week without significant adverse effects, the dose will be escalated in 5 mg per day increments at weekly intervals, with a maximum allowable dose of 15mg twice daily.
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.
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.
Time frame: At the 12-weeks
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.
Time frame: 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.
Time frame: At the weeks 1, 2, 4, 8, and 12
The average weekly consumption of rescue analgesics
Acetaminophen is permitted as rescue medication for intolerable FM-related pain. The maximum allowable dose is 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use will be recorded prospectively in patient diaries, including date, dose, and frequency of administration.
Time frame: At the weeks 4, 8, and 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.
Time frame: At the weeks 4, 8, and 12
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales
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.
Time frame: At the weeks 4, 8, and 12
The SF-36 is utilized to assess health-related quality of life, encompassing preference across different health states. It evaluates 8 distinct domains, with each domain scored on a scale ranging from 0 to 100, wher
The short-form 36 Health Survey (SF-36)
Time frame: At the weeks 4, 8, and 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.
Time frame: 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.
Time frame: At the weeks 4, 8, and 12
The Patient Global Impression of Change (PGIC) Scale
The PGIC is a 7-point patient-reported global rating scale that assesses overall change in health status since the start of treatment. Participants rate their condition as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Time frame: At week 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.
Time frame: Through study completion, an average of 12 weeks
Plan to share: 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.
Started Sep 2025 (actual). Primary completion is estimated for Jun 2027, 21 months after the start.
Of 438 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 21 months is above that.
Counting every sponsor, half of 451 studies reached it within 15 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Mirogabalin