The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia

November 22, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital, Beijing, Beijing 100070
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Monotherapy group
Pregabalin
Drug: Pregabalin
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.
Experimental: Combination therapy group
Pregabalin with dexmedetomidine
Drug: Pregabalin with dexmedetomidine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the 4-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The worst pain intensity
Time Frame: At the weeks 1, 2, 4, and 8
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.
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 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.
At the weeks 1, 2, 4, and 8
The Revised FM Impact Questionnaire
Time Frame: At the weeks 1, 2, 4, and 8
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.
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 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.
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 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).
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
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.
At the weeks 1, 2, 4, and 8
Adverse Events
Time Frame: Through study completion, an average of 8 weeks
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.
Through study completion, an average of 8 weeks
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales
Time Frame: At the weeks 1, 2, 4, and 8
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.
At the weeks 1, 2, 4, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025-217-03-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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