FibromyalgiaNCT07230197
The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia
A study testing Pregabalin and Pregabalin with dexmedetomidine 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, Dexmedetomidine
- What is being tested?
- Pregabalin and Pregabalin with dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 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 18 years or older;
- Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
- Numeric rating scale (NRS) score ≥ 4 at baseline;
- Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
Who cannot join
- History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;
- History of epilepsy, or depression requiring antidepressant medications;
- Pregnancy or breastfeeding;
- Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
- With acute or chronic pain conditions 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 With Pregabalin Combined Dexmedetomidine 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. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
- Conditions
- Fibromyalgia, Pregabalin, Dexmedetomidine
- Being tested
- Pregabalin, Pregabalin with dexmedetomidine
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily.
Pregabalin with dexmedetomidineDrug
In the pregabalin with dexmedetodimine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. The dose of dexmedetomidine administered via nasal spray is 4 sprays per day, with 1 spray in each nostril on both sides. The spray should be held for about 30 seconds before another 1 spray is administered in each nostril. A total of 4 sprays are given. The total dosage is 100 μg.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy group | Active comparator | Pregabalin Receives: Drug: Pregabalin |
| Combination therapy group | Experimental | Pregabalin with dexmedetomidine Receives: Drug: Pregabalin with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average pain intensity
The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Measured: At the 4-weeks
Secondary outcomes (8)
The worst pain intensity
The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. 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, and 8
The proportion of patients achieving pain reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline 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, and 8
The Revised FM Impact Questionnaire
The Revised FM Impact Questionnaire assesses the severity of FM symptoms and their impact on daily functioning. It evaluates three linked domains: function, overall impact, and symptoms, using a 0 to10 NRS. The total score ranges from 0 to 100, with higher scores indicating greater disease burden.
Measured: At the weeks 1, 2, 4, and 8
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales
BPI-S accesses pain intensity over the past 24 hours, calculated as the average of items 3 to 6 on the BPI, scored using a 0 to 10 NRS. In the NRS scale, 0 indicates no pain, while 10 represents the worst pain imaginable. The total score ranges from 0 to 40, with higher scores indicating greater pain severity. BPI-I evaluates the degree to which pain interferes with daily activities, including general activity, mood, mobility work, relationships, sleep, and pleasure. This subscale comprises 7 items, each scored from 0 (no interference) to 10 (complete interference), with a total score ranging from 0 to 70.
Measured: At the weeks 1, 2, 4, and 8
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 1, 2, 4, and 8
The Medical Outcomes Study Sleep Scale (MOS)
The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).
Measured: At the weeks 1, 2, 4, and 8
The Beck Depression Inventory-Ⅱ (BD-Ⅱ)
The BD-Ⅱ evaluates the severity of depressive symptoms using a 4-point scale from 0 to 3, where 0 indicates no symptom and 3 indicates severe symptomatology. It comprises 21 items, the total score ranging from 0 to 63.
Measured: At the weeks 1, 2, 4, and 8
Adverse Events
The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 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.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230197
- Sponsor's protocol ID
- KY2025-217-03-07
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 28 Nov 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Dexmedetomidine in the Treatment of Fibromyalgia: A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07230197
- Acronym / sponsor ID
- KY2025-217-03-07
- Conditions
- Fibromyalgia, Pregabalin, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Nov 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. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy group | Active comparator | Drug: PregabalinPregabalin |
| Combination therapy group | Experimental | Drug: Pregabalin with dexmedetomidinePregabalin with dexmedetomidine |
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 18 years or older;
- Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
- Numeric rating scale (NRS) score ≥ 4 at baseline;
- Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
Key exclusion criteria (5 listed)
- History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;
- History of epilepsy, or depression requiring antidepressant medications;
- Pregnancy or breastfeeding;
- Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
- With acute or chronic pain conditions 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 |
|---|---|---|
| PregabalinIn the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily. | Drug | Monotherapy group |
| Pregabalin with dexmedetomidineIn the pregabalin with dexmedetodimine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. The dose of dexmedetomidine administered via nasal spray is 4 sprays per day, with 1 spray in each nostril on both sides. The spray should be held for about 30 seconds before another 1 spray is administered in each nostril. A total of 4 sprays are given. The total dosage is 100 μg. | Drug | Combination therapy group |
Primary outcome
The average pain intensity
Time frame: At the 4-weeks
The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
8 secondary outcomes
The worst pain intensity
Time frame: At the weeks 1, 2, 4, and 8
The proportion of patients achieving pain reduction
Time frame: At the weeks 1, 2, 4, and 8
The Revised FM Impact Questionnaire
Time frame: At the weeks 1, 2, 4, and 8
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales
Time frame: At the weeks 1, 2, 4, and 8
The short-form 36 Health Survey (SF-36)
Time frame: At the weeks 1, 2, 4, and 8
The Medical Outcomes Study Sleep Scale (MOS)
Time frame: At the weeks 1, 2, 4, and 8
The Beck Depression Inventory-Ⅱ (BD-Ⅱ)
Time frame: At the weeks 1, 2, 4, and 8
Adverse Events
Time frame: Through study completion, an average of 8 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 28 Nov 2025.
- 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.
- Migliorini F, Maffulli N, Eschweiler J, Baroncini A, Bell A, Colarossi G. Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis. J Orthop Surg Res. 2023;18(1):504. doi: 10.1186/s13018-023-03995-z.Link provided by the sponsor.
- Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.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.
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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 Pregabalin with dexmedetomidine 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 28 Nov 2025. 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 (+8613611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average pain intensity (time frame: At the 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.