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

NCT07230197 | Recruiting DMC

• 1 other identifier: KY2025-217-03-07
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  At the 4-weeks

Secondary Outcomes (8)

• The worst pain intensity

  At the weeks 1, 2, 4, and 8

• The proportion of patients achieving pain reduction

  At the weeks 1, 2, 4, and 8

• The Revised FM Impact Questionnaire

  At the weeks 1, 2, 4, and 8

• The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales

  At the weeks 1, 2, 4, and 8

• The short-form 36 Health Survey (SF-36)

  At the weeks 1, 2, 4, and 8

Study Arms (2)

Monotherapy group

ACTIVE COMPARATOR

Pregabalin

Drug: Pregabalin

Combination therapy group

EXPERIMENTAL

Pregabalin with dexmedetomidine

Drug: Pregabalin with dexmedetomidine

Interventions

Pregabalin DRUG

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.

Monotherapy group

Pregabalin with dexmedetomidine DRUG

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.

Combination therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315
• 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.
• 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.

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin; Dexmedetomidine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Fang Luo

CONTACT

+8613611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)