RecruitingNot ApplicableNCT07230197

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

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Dexmedetomidine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Sponsor

Beijing Tiantan Hospital

Enrollment

400 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Dexmedetomidine Fibromyalgia Pregabalin

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria5

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.

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Interventions

DRUGPregabalin

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.

DRUGPregabalin 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.