The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia
Recruiting now · Not applicable
Conditions studied: Fibromyalgia, Pregabalin, Dexmedetomidine
In brief
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.
Key facts
- Study ID
- NCT07230197
- Run by
- Beijing Tiantan Hospital
- People needed
- 400
- Starts
- 2025-09-30
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2025-11-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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