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

Capital Medical University

Status: Enrolling

Conditions: Fibromyalgia; Dexmedetomidine; Pregabalin

Treatments: Drug: Pregabalin; Drug: Pregabalin with dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07230197

KY2025-217-03-07

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Monotherapy group

Active Comparator group

Description:

Pregabalin

Treatment:

Drug: Pregabalin

Combination therapy group

Experimental group

Description:

Pregabalin with dexmedetomidine

Treatment:

Drug: Pregabalin with dexmedetomidine